Lower Dose DFN-11 for Episodic Migraine Associated With Fewer Side Effects

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Individuals with episodic migraine were enrolled in a multicenter double-blind placebo-controlled study.
Individuals with episodic migraine were enrolled in a multicenter double-blind placebo-controlled study.

The following article is part of conference coverage from the PAINWeek 2018 conference in Las Vegas, Nevada. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from PAINWeek 2018.

Las Vegas — DFN-11, a 3 mg subcutaneous (SC) sumatriptan autoinjector, may provide an alternative to SC sumatriptan 6 mg for individuals with episodic migraine, as it was found to have a lower incidence of side effects and injection site reactions, according to a study presented at the 2018 PAINWeek conference, held September 4-8.

Individuals with episodic migraine were enrolled in a multicenter double-blind placebo-controlled study. They were randomly assigned 1:1 to receive DFN-11 or placebo the acute treatment of a migraine during the double-blind phase of the study. The participants were treated again during an 8-week open-label (OL) period to evaluate the safety and tolerability of DFN-11 administered during numerous migraines.

During the double-blind period, 7.2% of individuals taking DFN-11 (8 of 111) and 1.7% of those taking placebo (2 of 119) reported treatment-emergent adverse events (TEAEs). Paresthesia was the most common TEAE reported from patients who were administered DFN-11 (2.7%), and chest pain (1.7%) was more common in patients taking placebo. During the 8-week open-label period, the rate of TEAEs in individuals taking DFN-11 was 11.4% (25 of 219), and most were minor. 

During the double-blind period, injection site reactions were reported by 24 participants (21.6%) = who were taking DFN-11 and 14 individuals (11.8%) taking placebo. During the OL phase of the study, mild injection site reactions were seen in 50 participants (22.8%), and during 4 additional migraines, the incidence was 18.1%, 9.7%, 9.9% and 7.3%, respectively.   

The findings showed a low incidence of triptan-related side effects or injection site reactions. Researchers concluded that, "DFN-11, a low dose, 3 mg, SC sumatriptan autoinjector, may be an alternative to SC 6 mg."

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Reference

Munjal S, Landy S, Brand-Schiebert E, Rapoport A. Tolerability of DFN-11, low dose (3 mg) sumatriptan injection: Focus on triptan sensations and injection site reactions in the RESTOR episodic migraine study. Presented at: Pain Week; September 4-8, 2018; Las Vegas NV. Abstract 103.

For more coverage of PAINWeek 2018, click here.

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