Med Check: Naloxone and Opioid Overdose; Evekeo ODT and ADHD in Children; Theta Burst Protocol and Depressive Disorder; Brilaroxazine Phase 2 Trials

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Back to table of contents Previous article Next article Med CheckFull AccessMed Check: Naloxone and Opioid Overdose; Evekeo ODT and ADHD in Children; Theta Burst Protocol and Depressive Disorder; Brilaroxazine Phase 2 TrialsTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:28 May 2021https://doi.org/10.1176/appi.pn.2021.6.14Higher Naloxone Dose Approved for Opioid OverdoseIn April the Food and Drug Administration (FDA) approved Kloxxado, a higher dosage of naloxone nasal spray for the emergency treatment of known or suspected opioid overdose. The newly approved product, developed by Hikma Pharmaceuticals, delivers 8 mg of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.The FDA approved Kloxxado based on previous findings about the safety and effectiveness of Narcan injection (naloxone hydrochloride) for treating opioid overdose. Hikma Pharmaceuticals also submitted its own safety and effectiveness data.“Over the last several years, the FDA has taken a number of steps to improve availability of naloxone products, including encouraging manufacturers to pursue approval of over-the-counter naloxone products; requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information; and extending the shelf life of naloxone nasal spray from 24 months to 36 months,” the agency said in a statement.Evekeo ODT Approved for ADHD in Young ChildrenIn April the FDA approved Evekeo ODT (amphetamine sulfate) by Arbor Pharmaceuticals for treating attention-deficit/hyperactivity disorder (ADHD) in patients aged 3 to 5 years. Evekeo ODT, a mixture of dextroamphetamine sulfate and levoamphetamine sulfate, was previously approved for treating ADHD in patients aged 5 to 17 years, with tablets ranging in dose from 5 mg to 20 mg. Evekeo ODT will be available in a new 2.5 mg orally disintegrating tablet for patients 3 to 5 years old. The recommended starting dose for patients in this age group is 2.5 mg daily, and a second dose may be administered after 4 to 6 hours.Evekeo ODT is a Schedule II controlled substance and comes with a boxed warning noting that central nervous systems stimulants have a high potential for abuse and dependence. The boxed warning advises health professionals to assess their patients’ risk of abuse and dependence before prescribing the drug, and to monitor patients for signs of abuse and dependence as therapy continues.Theta Burst Protocol Cleared for Treating Major Depressive DisorderBrainsWay announced in April that its Theta Burst protocol has been approved by the FDA for treating major depressive disorder. Theta Burst is a three-minute protocol that uses the company’s Deep Transcranial Magnetic Stimulation (Deep TMS) system. TMS uses magnetic fields to stimulate parts of the brain and activate neural pathways to improve symptoms of depression.In a study of 146 patients with major depressive disorder, patients treated with the three-minute protocol experienced reductions in depression scores similar to those who received the standard 20-minute sessions, the company said in a statement. The standard treatment protocol consists of 20-minute sessions five times a week for four to six weeks, followed by treatment twice a week for up to 12 weeks as needed for maintenance.Brilaroxazine Promising in Phase 2 TrialsReviva Pharmaceuticals’ investigational drug brilaroxazine appeared to be safe and effective for treating schizophrenia and schizoaffective disorder in a phase 2 clinical trial, the company announced in April.In the trial, 234 adults who had acute exacerbation of schizophrenia or schizoaffective disorder were randomized to receive either treatment with brilaroxazine or placebo for four weeks. The primary endpoint was reduction in total Positive and Negative Syndrome Scale (PANSS) from baseline to the end of the treatment. At the end of four weeks, the PANSS total score was reduced by 20 points in patients who took brilaroxazine, which the company said in a statement is a “statistically significant treatment difference from the placebo.” ■ ISSUES NewArchived