Abilify Maintena Research Articles

Abilify Maintena 400 mg (aripiprazole once-monthly), two-injection start (TIS) regimen: the experience of the Psychiatric Unit (SPDC) of Rimini

Introduction The single-injection start regimen for aripiprazole once-monthly 400 mg (AOM 400) in patients with schizofrenia requires a single intramuscular injection in the gluteal or deltoid site and 14 days of concurrent oral therapy. Based on a population-pharmacokinetic model, the European Medicines Agency and Canada has recently approved a simplified starting strayegy of aripiprazole once a month with single-day regimen of two injections at separate gluteal and deltoid injection sites, together with a single 20 mg dose of oral aripiprazole on the 1st day.ObjectivesThe aim of the study is to evaluate the two injection start (TIS) regimen in inpatients in the Psichiatric Unit (SPDC) of the Hospital of Rimini.MethodsWe retrospectively reviewed medical records of patients, from February 2021 to April 2023, that have more than 18 years, who received the newly approved 2-injection start regimen as part of their standard care, evaluating if exist changes in clinical indicators, safety and tolerability of this regimen.We valuated retrospectively the days of hospitalization after the aripiprazole 400 mg TIS and the number of emergency room access, analyzing the “repository of AUSL della Romagna” and discharge letters and the “CURE” program of the Psychiatric Service of Rimini.ResultsWe evaluated 24 patients from February 2021 to April 2023, 11 male (45,8%), 13 female (54,2%); average age 37,95, average lenght of stay in hospital was 11,75 days. 10 patients with diagnosis of psychosis/schizophrenia (41,7%), 6 patients with bipolar disorder (25%), 4 patients with personality disorder (16,6%), 2 patients with substance induced psychosi (8,3%), 1 patients with delusional disorder (4,2%), 1 patient with schizoaffective disorder (4,2%). 6 patients had the two-injection start regimen in 2021 (25%), 13 patients in 2022 (54,2), 5 patients in 2023 (20,8%); 20 patients did not have admission in hospital after the TIS (83,3%), 4 patients had 1 or more admission after the injection (16,7%). 3 patients (12,5%) had accesses in emergency-room after Abilify Maintena. 15 patients (62,5%) continue therapy; 9 patients (37,5%) had suspended the injection for drop-out or because of change of therapy not correlated at adverse effects (1 female patient had suspended treatment after the two-injections due to pregnancy). Just 1 patient that continue Abilify Maintena 400 mg had 2 accesses in the emergency-room.ConclusionsThe coadministration of 2 injections of 400 mg aripiprazole was not associated with safety concerns beyond those expected with a single-injection start regimen. From the study it appears that the long-acting therapy with Alibify Maintena 400 mg once-monthly helps to stabilize the patient to prevent hospitalization and accesses in emergency-room.Disclosure of InterestNone Declared

Med Check: Zuranolone for Depression, Uzedy for Schizophrenia, and More

Back to table of contents Previous article Next article Med CheckFull AccessMed Check: Zuranolone for Depression, Uzedy for Schizophrenia, and MoreTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:25 May 2023https://doi.org/10.1176/appi.pn.2023.06.6.1Zuranolone Found to Quickly Reduce Major Depression SymptomsAdults with major depressive disorder may experience mood improvements within days of taking zuranolone (50 mg/day), a study published in May in The American Journal of Psychiatry (AJP) suggests. Zuranolone is an oral, once-daily neuroactive steroid that acts on GABA-A receptors.The phase 3 trial included patients who were between the ages of 18 and 64 years, had received a diagnosis of major depressive disorder, had been experiencing symptoms of depression for a least four weeks, and had a Hamilton Depression Rating Scale (HAM-D) score of at least 24 at screening and before they started taking the assigned study medication.The researchers randomized 534 participants to take either 14 days of treatment with zuranolone 50 mg/day or placebo in the evening. The researchers evaluated the participants 10 times over the course of the 42-day trial using such assessments as the HAM-D, the Columbia–Suicide Severity Rating Scale, the Clinical Global Impressions severity score, and more.Compared with patients who took placebo, those who took zuranolone demonstrated a statistically significant improvement in depressive symptoms at day 15. “Numerically greater improvements in depressive symptoms for zuranolone versus placebo were observed by day 3 (least squares mean change from baseline HAM-D score, −9.8 vs. −6.8), which were sustained at all visits throughout the treatment and follow-up periods of the study,” the researchers wrote.FDA Approves Uzedy for Treating SchizophreniaIn April the U.S. Food and Drug Administration (FDA) approved Uzedy (risperidone extended-release injectable suspension) for the treatment of schizophrenia in adults, Teva and MedinCell announced. Uzedy is a long-acting subcutaneous antipsychotic that may be given in one- or two-month dosing intervals.In the phase 3 RISE trial, 544 patients aged 13 to 65 years with schizophrenia were randomized to receive a subcutaneous injection of Uzedy (either once per month or once every two months) or placebo. Those who received Uzedy once per month or once every two months had a reduction of 80.0% and 62.5% in the risk to relapse compared with those who received placebo, respectively. Results were similar in the phase 3 SHINE trial, which examined the long-term safety of the drug for up to 56 weeks in 336 patients aged 13 to 65 years with schizophrenia.A companion survey of participants in the SHINE trial found that 89% of patients and 92% of health professionals rated administration of Uzedy as easy when asked how easy or difficult it was to receive or administer the medication in its current form. Further, 70% of patients reported that Uzedy provided a better injection experience than their previous long-acting injectables (LAIs).Abilify Asimtufii Approved for Schizophrenia, Bipolar I TreatmentAbilify Asimtufii (aripiprazole extended release injectable suspension) has been approved by the FDA for the treatment of schizophrenia in adults and as a monotherapy treatment of bipolar I disorder in adults, Otsuka and Lundbeck announced in April. Abilify Asimtufii is a long-acting subcutaneous atypical antipsychotic that may be given every two months.The approval was based on safety and efficacy data from trials of Abilify Maintena, which is for once monthly dosing, and on the results of a phase 1-2 study. In the phase 1-2 study, 266 adults with schizophrenia or bipolar I disorder were randomly assigned to receive either Abilify Asimtufii 960 mg every 56 days, for a total of four injections or Abilify Maintena 400 mg administered every 28 days for a total of eight injections. Treatment with Abilify Asimtufii resulted in similar aripiprazole plasma concentrations and efficacy to Abilify Maintena. ■ ISSUES NewArchived

Effectiveness and quality of life improvement in young adult schizophrenia patients treated with Abilify Maintena

IntroductionTreating young patients with schizophrenia is a challenge, as these patients have much to gain from controlled pharmacotherapy and even more to lose with a possible relapse. Treating patients with long-acting injectable antipsychotics avoids the issue of non-compliance, the biggest risk factor for relapse, while also improving the quality of life. Receiving a drug once-a-month can provide greater flexibility and convenience to our patients.ObjectivesAim of the paper is to assess the efficacy and quality of life in monthly dosing of long-acting injectable antipsychotic in young adult schizophrenia patients.MethodsThe research included 7 patients aged 19 to 25 years who were diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Patients were assessed eight times over two years using the following clinical scales: Positive and Negative Syndrome Scale, Clinical Global Impression – Severity and Improvement Scale, Treatment Satisfaction Questionnaire for Medication (TSQM-9) and Quality of Life Scale (QOLS).ResultsAll treated patients achieved remission. There was a statistically significant improvement in measured scales in all patients. There were no side-effects reported during the study period, with no relapse or new hospitalizationsConclusionsThe monthly formulation of aripiprazole has proven to be effective and safe in our study and has great potential to improve patient quality of life as well.Disclosure of InterestNone Declared

PSYCHOTIC PATIENT AND AFFECTATION OF THE SEXUAL SPHERE. ABOUT A CLINICAL CASE

IntroductionClinical case description.A 44-year-old male, with paranoid schizophrenia, polydrug addict and IVDU since he was 14 years old. Live alone. He is brought by the Local Police for heteroaggressiveness when he was arrested for trespassing and resisting authority. He has presented 14 hospital admissions and therapeutic communities for detoxification since 2000.Objectives1. To analyze the causes of abandonment of treatmentMethods1.Complete medical history2.Blood test with hormone profile3.PRAEQ QuestionnaireAbsence of child psychopathology until the age of 6, at which time his parents separate and he becomes introverted, with solitary activities and distractions. On examination, the patient is restless. Psychotic contact. Delusional speech centered on ill-structured ideas of harm, persecution and grandiose, being difficult to explore due to lack of collaboration on the part of the patient, who only accepts treatment with aripiprazole 5 mg due to sexual dysfunction with the rest of the treatments.ResultsDuring his admission, he has evolved from a very unstructured delusional theme and social isolation, with lax and tangential speech and refusal to take any treatment except aripiprazole, towards a cooperative, trusting attitude, with attenuation of his delusional ideation, with appropriate, organized and releasable. Treatment with IM aripiprazole is agreed upon for discharge.Clinical judgement: Paranoid schizophrenia (F20.0)ConclusionsWith this case, we intend to remember that antipsychotics affect different spheres of the patient’s life that can hinder adherence to treatment, and that we often do not take into account. In this specific case, Abilify Maintena is useful because it does not cause sexual dysfunction, which facilitates treatment adherence and greater patient involvement, which gives us greater opportunities for social integration.Disclosure of InterestNone Declared

Treatment with aripiprazole once-monthly injectable formulation is effective in improving symptoms and global functioning in schizophrenia with and without comorbid substance use - a post hoc analysis of the ReLiAM study.

ReLiAM, Real-Life Assessment of Abilify Maintena, was the first reported long-term prospective non-interventional study for patients with schizophrenia treated with aripiprazole once-monthly injectable formulation (AOM) under real-life conditions. ReLiAM's primary aim was to evaluate the evolution of global functional status in patients treated with AOM for 12months in Canada. The objective of this post hoc analysis of the ReLiAM study is to investigate the treatment effects of real-life use of AOM over a 1-year period in the subgroup of patients with reported substance use compared with patients without substance use. The results of this post hoc analysis demonstrate that treatment with AOM for 12months in patients with schizophrenia was comparably effective in improving global functioning in subgroups of patients with and without concomitant substance use. These results support the use of AOM for the treatment of schizophrenia in patients with or without concomitant substance use. ClinicalTrials.gov NCT02131415, first posted on May 6, 2014. Overall trial status: Terminated.

Impact of 3-Monthly Long-Acting Injectable Paliperidone Palmitate in Schizophrenia: A Retrospective, Real-World Analysis of Population-Based Health Records in Spain.

BackgroundTreatment of schizophrenia requires long-term medication to prevent relapse. Treatment nonadherence may increase the risk of relapse, leading to increased hospitalizations and emergency room (ER) visits. Long-acting injectables (LAIs) such as paliperidone palmitate have improved treatment adherence and therefore symptoms. However, real-world studies comparing 3-monthly LAI formulations with other LAIs and oral antipsychotics (OAs) are scarce.ObjectiveThe objective of this study was to investigate and evaluate the clinical effectiveness of paliperidone palmitate LAI monthly (PP1M; Xeplion®) and 3-monthly (PP3M; Trevicta®) formulations compared with the monthly LAI aripiprazole (AM; Abilify Maintena®) and OAs in Spain.MethodsThis was a retrospective, observational study including 2275 adult patients with schizophrenia in a Spanish population. Data from hospital, primary care, and pharmacy dispensation electronic medical records were obtained between January 2017 and February 2018. The main outcomes included psychiatric hospitalizations and ER visit rates, days on treatment, and treatment persistence.ResultsPatients receiving PP3M had a significantly lower mean hospitalization rate (0.00046 ± standard deviation [SD] 0.00181; p < 0.0001) than other treatment groups. Kaplan–Meier curves revealed that 92.0 and 88.4% of patients receiving PP3M remained hospitalization free by 12 and 18 months, respectively. All treatment groups had at least a twofold significantly higher risk of psychiatric hospitalizations compared with those receiving PP3M or OAs, and the hospitalization risk among the PP3M group was significantly lower (hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.31–0.67). The risk of ER visits was significantly lower with both PP3M and PP1M than with OAs, and lowest with PP3M (HR 0.462 [95% CI 0.29–0.62] and HR 0.833 [95% CI 0.59–0.97], respectively). Time until treatment switch with PP3M was high, with more than 86.5% of patients remaining on treatment at 18 months.ConclusionsPP3M was more effective than OAs and monthly LAIs in improving clinical outcomes for patients with schizophrenia in a real-world setting in Spain.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40263-022-00917-1.

A safety evaluation of aripiprazole in the treatment of schizophrenia

ABSTRACT Introduction Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agonism and antagonism at serotonin 5-HT2A receptors. Areas covered We review short-and-long-term clinical trials, meta-analyses of clinical trials and product information pertaining to the safety and efficacy of aripiprazole in adults with schizophrenia. Formulations of aripiprazole reviewed include oral aripiprazole, Aripiprazole monohydrate LAI (Abilify Maintena©) and Aripiprazole lauroxil LAI (Aristada©). Clinical studies and product information were collected from PubMed, Psychinfo, Embase, and other web sources. Expert opinion Aripiprazole is a generally well-tolerated third-generation antipsychotic with low rates of motor side effects and metabolic adverse effects that occur commonly with several alternative antipsychotics. Akathisia and tremor appear to occur at higher rates with aripiprazole compared to placebo but are still generally uncommon with incidences of 10–11% or less. Uniquely, aripiprazole treatment is associated with reduced serum prolactin levels and QTc interval. A variety of LAI options with dosing intervals as infrequent as every 8 weeks provide a compelling reason to select aripiprazole in patients with limited oral treatment adherence.

The effectiveness of long-term aripiprazole injections to a patient with paranoid schizophrenia: a case report

Abstract Paranoid schizophrenia is a chronic, psychotic disorder which can be treated with long-acting injectable (LAI) antipsychotic drugs. There are risperidone (Risperdal Consta®), olanzapine (Zypadhera®), paliperidone (Xepilon®) and aripiprazole (Abilify Maintena®) currently available. The aim of this study was to present a case history of the patient to whom monthly injections of aripiprazole effectively prevented both relapses of psychotic symptoms and hospitalizations. Case report: A 55-year-old male patient with a 13-year history of paranoid schizophrenia has been effectively treated with aripiprazole (LAI) (400mg, every 4 weeks). During the last 8 years of treatment his mental state has been stabilized, without any acute psychotic symptoms and without any anxiety, or violent behaviours. Moreover, there have been no psychotic symptoms, or suicidal thoughts, or tendencies recordered. Therefore, no hospitalization has been required. However, despite the treatment, negative symptoms such as blunted affect, cognitive dysfunction and social withdrawal have been sustained. Discussion: The available articles on aripiprazole (LAI) treatment indicate that it was effective in reducing the positive and negative symptoms of schizophrenia, as well as reducing the frequency and duration of hospitalization. However, the case report of a patient who has not had relapses of psychotic symptoms and suicidal thoughts and has not been hospitalized during 8 years of treatment with aripiprazole (LAI) has not yet been reported. Conclusions: Regular, long-term injections of aripiprazole (LAI) are very effective at preventing positive symptoms of schizophrenia development and preventing both suicidal thoughts and hospitalizations. Therefore, treatment with this drug in everyday practice should be increased.

Worsening of Psychotic Symptoms in Patients with Chronic Schizophrenia after Switching to or Combining Aripiprazole and Aripiprazole Monthly (Abilify Maintena)

Worsening of Psychotic Symptoms in Patients with Chronic Schizophrenia after Switching to or Combining Aripiprazole and Aripiprazole Monthly (Abilify Maintena)

Impact of a pharmacist‐administered long‐acting injectable antipsychotic service in a supermarket‐based community pharmacy on medication adherence

AbstractIntroductionLong‐acting injectable antipsychotic (LAIA) medications can improve medication adherence in patients with schizophrenia and bipolar disorder due to their 1‐ to 3‐month administration schedules.ObjectivesThe primary objective of this study was to examine the effect of a pharmacist‐administered LAIA service in a supermarket‐based community pharmacy on medication adherence rates.MethodsIn this descriptive study, service data from July 1, 2017 through February 28, 2018 were obtained from a national chain pharmacy. The study population included all patients utilizing the pharmacist‐administered LAIA service who received one of the following LAIA medications during the study period: aripiprazole, aripiprazole lauroxil, paliperidone palmitate, and risperidone. Patients under the age of 18 and those who received fewer than two pharmacist administrations of the same medication were excluded. Medication adherence was measured using the proportion of days covered (PDC) with ≥80% being considered adherent. Logistic regression analysis was performed to identify factors that affected PDC.ResultsA total of 78% (500/641) of patients enrolled in the service were determined to be adherent to their LAIA. Statistically significant differences were found between PDC rates based on medication selection. Using aripiprazole (Abilify Maintena) as a reference, patients on paliperidone palmitate (Invega Sustenna), paliperidone palmitate (Invega Trinza), and risperidone (Risperdal Consta) were 2.1 (95% CI 1.3‐3.3, P &lt; .002), 4.4 (95% CI 1.8‐11.2, P &lt; .002), and 4.3 (95% CI 1.6‐11.8, P &lt; .004) times more likely to have a PDC ≥80%, respectively.ConclusionA majority of patients (78%) enrolled in a community pharmacy‐based service in which pharmacists‐administered LAIA medications were shown to be adherent to their medication. Specific LAIA medications were found to be associated with greater medication adherence. Findings from this study will provide insight into effective means of care delivery for other community‐based specialty pharmacy programs.

The effect of aripiprazole once-monthly on personal and social functioning: post hoc analyses of acute and long-term studies.

ObjectiveTo evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®) on personal and social functioning in patients with schizophrenia in both the acute treatment and maintenance therapy settings.MethodsPost hoc analyses were conducted on data from Study 291 (NCT01663532), a 12-week, randomized, double-blind, placebo-controlled trial conducted in patients who were experiencing an acute psychotic episode, and Study 248 (NCT00731549), a 52-week open-label extension of two randomized, controlled trials of AOM 400 as maintenance therapy. Assessment of functioning was made using the Personal and Social Performance (PSP) scale. In Study 291, results were stratified by age (≤35 years or >35 years).ResultsIn Study 291, 340 patients were included in the analysis (n=168 randomized to AOM 400 [n=49 aged ≤35 years, n=119 aged >35 years]; n=172 randomized to placebo [n=54 aged ≤35 years, n=118 aged >35 years]). In Study 248, 1,081 patients entered the open-label maintenance phase and 858 completed the study. In Study 291, AOM 400, compared with placebo, resulted in a significant increase (improvement) in PSP scores based on LSM (SE) changes from baseline to Week 12 in patients aged ≤35 years (20.6 [1.9] for AOM 400 vs 9.5 [2.4] for placebo; P=0.001) and a numerically (but not significantly) larger increase in PSP scores in patients aged >35 years (16.1 [1.7] for AOM 400 vs 12.5 [1.9] for placebo; P=0.093). Improvements in both age groups met criteria for a minimally important clinical difference (7–10 points). In Study 248, AOM 400 resulted in either numerical improvements (increases) from baseline in PSP total score or maintenance of stable baseline values throughout the study.ConclusionAOM 400 was effective in improving personal and social functioning during acute treatment and maintaining function during long-term treatment.

Symptomatic stability with aripiprazole once-monthly: efficacy analyses from acute and long-term studies.

Objective: To evaluate the effect of aripiprazole once-monthly 400 mg (AOM 400; Abilify Maintena®) on symptom stability in acute treatment and maintenance therapy settings in patients with schizophrenia.Methods: Results were analyzed from two pivotal maintenance studies (Studies 246 and 247), a long-term (52 weeks), open-label extension of these studies (Study 248), an open-label, mirror-image study in patients switching from oral to long-acting injectable antipsychotic therapy (Study 283), and a study of AOM 400 in the acute setting (Study 291). Symptom stability was assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression (CGI) scale (CGI-Severity of Illness and CGI-Improvement). Results are reported for the total study population and in subgroups stratified by age.Results: In Study 246, AOM 400 resulted in significantly greater improvements from baseline vs placebo on all measures of symptom stability, with improvements maintained through 52 weeks. In Study 247, a non-inferiority study, AOM 400 resulted in improvements in PANSS and CGI scores comparable or significantly greater at all timepoints vs oral aripiprazole. In Study 248, AOM 400 resulted in the long-term stability of symptom improvements from the earlier studies. In Study 283, AOM 400 resulted in significant improvements from baseline in PANSS and CGI scores over 24 weeks. In Study 291, AOM 400 resulted in significantly greater improvements from baseline in PANSS and CGI scores vs placebo at all post-baseline timepoints. In post hoc analyses, AOM 400 showed similar efficacy in symptom improvement in adult patients aged ≤35 years and >35 years, with some evidence of a larger treatment effect on PANSS negative symptoms among younger patients in the acute treatment setting.Conclusion: In acute treatment and maintenance therapy settings, AOM 400 was effective in the rapid stabilization and long-term maintenance of symptoms in patients with schizophrenia.

Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, Date of authorisation: 14/11/2013, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, Date of authorisation: 14/11/2013, Revision: 15, Status: Authorised

Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study

BackgroundWith previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada.MethodsFollowing their clinicians’ decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed.ResultsA majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients.ConclusionsTreatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight.Trial registrationUnique identifier: NCT02131415. First posted: 06 May 2014.

Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, Date of authorisation: 14/11/2013, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, Date of authorisation: 14/11/2013, Revision: 14, Status: Authorised

Process control and in vitro/in vivo evaluation of aripiprazole sustained-release microcrystals for intramuscular injection

This work describes the preparation of aripiprazole sustained-release microcrystals for intramuscular injection, through recrystallization, drying, wet grinding, and solidification steps, which had a great impact on the product quality. Here, we evaluated the crystal form of the drug in each step by differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and fourier transform infrared spectroscopy (FT-IR), demonstrating that there is no change in the crystal form of aripiprazole monohydrate (H1) during grinding and freeze-drying. Microscopy and scanning electron microscopy (SEM) data showed that freeze-drying had no effect on the morphology of milled H1, and thermal gravimetric analysis (TGA) results showed that the freeze-dried formulation had acceptable water content. In particular, in this study, a similarity factor fitting was applied to determine the similarity of the particle size cumulative distribution curve, and the similarity factor value (99.00) showed that there was no change in the particle size distribution before and after freeze-drying. A two-chamber transmembrane method was used to investigate the in vitro release of the aripiprazole sustained-release microcrystal (ALSI) and commercial preparations (Abilify Maintena®). The similarity factor fitting of in vitro release profiles and drug cumulative release curves in vivo yielded similarity factor values of 98.00 and 95.43, respectively, indicating similar in vitro release and in vivo bioavailability of rats between the ALSI and Abilify Maintena®. A single-dose administration could produce long-term effects for a month. For a microcrystalline suspension, in addition to the conventional quality control indicators, the similarity of the cumulative particle size distribution, the in vitro release profile, and the similarity of the drug release percentage in vivo can be used to reflect product quality and process control.

Med Check

Back to table of contents Previous article Next article Clinical and Research NewsFull AccessMed CheckNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:31 Aug 2017https://doi.org/10.1176/appi.pn.2017.9a8Injectable Aripiprazole for Bipolar I Disorder The Food and Drug Administration (FDA) has approved Abilify Maintena—a once-monthly injectable formulation of the antipsychotic aripiprazole—for the maintenance of bipolar I disorder in adults. Abilify is manufactured by Otsuka and Lundbeck. This approval was based on a large, year-long phase 3 study in adults aged 18 to 65 with bipolar disorder I. Abilify Maintena significantly delayed time to recurrence of any mood episode during the study compared with placebo. The trial also found significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes.“Abilify Maintena provides health care professionals a new treatment option for their patients who have established tolerability with oral aripiprazole,” said Joseph Calabrese, M.D., director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, in a press release from Otsuka. He added that concomitant oral antipsychotic medication must be administered for 14 days after the first injection.New Opioid Agent Cuts Pain Without Euphornia Nektar Therapeutics announced positive results from a Human Abuse Potential (HAP) study of its opioid analgesic NKTR-181—a mu-opioid agonist designed to provide potent pain relief without the euphoria that can lead to opioid abuse and addiction.The NKTR-181 HAP study evaluated the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose (400 mg) and at supratherapeutic doses (600 mg and 1,200 mg). The study found that NKTR-181 had significantly lower peak and average ratings of drug liking at 400 mg as well as the supratherapeutic dose of 600 mg compared with common therapeutic doses of oxycodone (40 mg or 60 mg). NKTR-181 1,200 mg had comparable drug liking to 60 mg of oxycodone.Nektar had previously completed a phase 3 efficacy trial in March 2017 demonstrating positive results in 610 opioid-naïve patients with moderate to severe chronic low back pain. That study also demonstrated a favorable safety and tolerability profile.The FDA has granted NKTR-181 a Fast Track designation for the treatment of moderate to severe chronic pain.Insomnia Medication Passes Phase 2 HurdleIdorsia’s experimental insomnia candidate ACT-541468 has met its primary endpoints in a pair of phase 2 trials, setting the stage for a phase 3 study of this dual orexin receptor antagonist (DORA).For the first study, researchers randomly assigned 360 adults aged 18 to 64 to one of three doses of ACT-541468 (5 mg/d, 10 mg/d, or 25 mg/d), zolpidem (10 mg/d), or placebo for four weeks. Participants taking ACT-541468 showed a significant dose-dependent decrease in wake time after sleep onset over zolpidem, with improvements being evident within two days. Participants in the ACT-541468 group also appeared to fall asleep faster. The treatment was generally well tolerated, and there were no reports of serious adverse events.In a separate study of 58 older patients aged 65 and older, ACT-541468 showed similar safety and efficacy.“The positive results of the phase 2 program demonstrate that our DORA can deliver on the potential its mechanism of action offers in insomnia,” Guy Braunstein, M.D., the head of Global Clinical Development at Idorsia, said in a press release. 23andMe Initiates Genetic Study of Depression, Bipolar DisorderThe genetic testing company 23andMe is partnering with the Milken Institute and Lundbeck on a new genetic study of major depressive disorder (MDD) and bipolar disorder (BD).This first-of-its-kind study aims to enroll 25,000 participants (15,000 with MDD and 10,000 with BD) to learn how genes and environment affect brain processes in people with these two conditions. The study will acquire data through genotyping, cognitive assessments, and participant survey responses.The study is open to individuals in the United States aged 18 to 50 who have a diagnosis of MDD or BD and been prescribed medication to treat their condition; they must also have a computer with Internet access. More details can be accessed here. ■ ISSUES NewArchived

Journal Digest

Journal Digest

Long-term inyectable antipsychotics in adolescents. A case report

IntroductionActually psychiatrists around the world are treating children and adolescents (despite limited medical indications in this age group) with atypical antipsychotics at increasing rates for a range of psychiatric illnesses (schizophrenia, bipolar disorder, behavioral changes…). Over the last few years, a number of new long-term injectable treatments (ILD) have emerged, the advantages of which are found in adult (adherence, functionality, consistent blood level without daily peaks…) but we do not have enough data in minors.ObjectivesDiscuss utility of ILD in adolescents.MethodsWe expose a case report about a 17-year-old man, when he was a child he was diagnosed with attention deficit disorder and autism spectrum disorder and also he had a story of disrupted behavioural and aggressively. After been hospitalized in our hospital we remake his clinic history and he was diagnosed with schizophrenia. Before the injectable treatment (ABILIFY MAINTENA®) this patient tried various treatments (mood stabilizers, antidepressants…) and many hospitalizations.ResultsAfter the ILD, our patient has good functionality, he is now living with his parents and studying in the high school. He has not needed another hospitalization after the last one.ConclusionsThe ILD in adolescents must be a therapeutic option in mental disease, in this group is very difficult the complementation of the treatment, it's frequent the comorbid use of substances, this population are not used to take medications… so every treatment that facility this kind of problems must be a perfect weapon to improve their mental health and to prevent relapse and hospitalization.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Stressors in patients with schizoaffective disorder

Patients with schizoaffective disorder have recurrent episodes of a mood disorder with severe psychotic symptoms. In many cases, patients have toxic abuse in some situations that could cause confusion in symptoms and ranking it. It is about a patient diagnosed 5 years ago of schizoaffective disorder with decompensation caused by leaving medication and drug consumption. A year ago, the treatment was changed to intramuscular formulation with abilify maintena to ensure compliance and adherence. The patient continues to consume toxic in weekends, with symptoms of self-referentiality and suspicion towards their environment. Two weeks ago, he was with the girlfriend of a friend and after this event, the friend has been threatening him. The patient has a state of anxiety rising, with interpretations and associations delirious about this friend. He sleeps with a knife in bed if the friend entered his home. It is a very overwhelmed situation, magnifying and causing severe impact on their underlying disorder. When the patient is evaluated, it is decided to add treatment with olanzapine a few days to reduce symptoms and anxiety. Patients with mental disorders have stressors that cause anxiety like a healthy patient. It is true that the impact it has on the patients tend to be older and to overvalue the signs and real situations. In these cases should not be considered a decompensation and attribute symptoms to lack of efficacy of treatment. In many cases, if we associate a more sedating antipsychotic profile, they shall reduce symptoms.Disclosure of interestThe authors have not supplied their declaration of competing interest.