Abstract
BackgroundDFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). This composition of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation and exhibit pharmacokinetics comparable to subcutaneously administered sumatriptan. Rapid rate of absorption is suggested to be important for optimal efficacy. The objective of this study was to evaluate the safety and tolerability of DFN-02 (10 mg) in the acute treatment of episodic migraine with and without aura over a 6-month period based on the incidence of treatment-emergent adverse events and the evaluation of results of clinical laboratory tests, vital signs, physical examination, and electrocardiograms.MethodsThis was a multi-center, open-label, repeat-dose safety study in adults with episodic migraine with and without aura. Subjects diagnosed with migraine with or without aura according to the criteria set forth in the International Classification of Headache Disorders, 2nd edition, who experienced 2 to 6 attacks per month with fewer than 15 headache days per month and at least 48 headache-free hours between attacks, used DFN-02 to treat their migraine attacks acutely over the course of 6 months.ResultsA total of 173 subjects was enrolled, 167 (96.5%) subjects used at least 1 dose of study medication and were evaluable for safety, and 134 (77.5%) subjects completed the 6-month study. A total of 2211 migraine attacks was reported, and 3292 doses of DFN-02 were administered; mean per subject monthly use of DFN-02 was 3.6 doses. Adverse events were those expected for triptans, as well as for nasally administered compounds. No new safety signals emerged. Dysgeusia and application site pain were the most commonly reported treatment-emergent adverse events over 6 months (21% and 30.5%, respectively). Most of the treatment-emergent adverse events were mild. There were 5 serious adverse events, all considered unrelated to the study medication; the early discontinuation rate was 22.5% over the 6-month treatment period.ConclusionDFN-02 was shown to be well tolerated when used over 6 months to treat episodic migraine acutely.
Highlights
DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeationenhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM)
With efficacy expected based on PK equivalency data, the sole objective of this study was to evaluate the safety and tolerability of DFN02’s unique formulation in the acute treatment of migraine over a 6-month period, based on treatmentemergent adverse events (TEAEs), clinical laboratory results, and electrocardiograms
Adverse events with DFN-02 were similar in pattern, frequency, and severity to those seen in previous research with triptans and nasally administered medications [17, 35], and no novel safety signals were seen
Summary
DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeationenhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). Poor absorption and relatively delayed onset of action limit the clinical utility of all oral triptans [4, 6]. Poor absorption is a problem with intranasal zolmitriptan (Tmax ~3 h) [19], and sumatriptan nasal powder has reported a Tmax of 20 min to as long as 2 h [20, 21]. These important clinical limitations, in light of the attributes of acute treatment that are most important to migraineurs (rapid onset of action, complete relief, no recurrence, lack of side effects [22–24]) highlight a gap in migraine pharmacotherapy and emphasize the unmet need for a safe and highly effective non-oral migraine medication with a rapid onset of action
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