An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)

Summary

A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.

Timeline

Start

2016-07-11

Primary completion

2017-02-10

Completion

2017-02-10

Outcome

Met primary endpoint

paper The study met its primary endpoint; the proportion of subjects who were free from headache pain at 2 hours postdose, was statistically significantly higher PMID 29878341 ↗

paper LOCF (DFN-02, n = 21/48; placebo, n = 9/40; 43.8% vs 22.5%, P  = .044) PMID 29878341 ↗

Publications

• Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment. CNS Drugs. 2019 Apr;33(4):375-382. doi: 10.1007/s40263-019-00614-6.
• Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02 (Sumatriptan 10 mg With a Permeation Enhancer) Nasal Spray vs Placebo in the Acute Treatment of Migraine: A Double-Blind, Placebo-Controlled Study. Headache. 2018 May;58(5):676-687. doi: 10.1111/head.13309.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sumatriptan	Unknown	10 mg	Intranasal

Indications