Lower Dose DFN-11 for Episodic Migraine Associated With Fewer Side Effects
Individuals with episodic migraine were enrolled in a multicenter double-blind placebo-controlled study.
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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."
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.
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