|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO — Results from the RESTOR study showing a low-dose sumatriptan autoinjector was well-tolerated, safe, and effective in treating acute migraines were presented at the American Headache Society’s 60th Annual Scientific Meeting, held June 28–July 1, 2018, in San Francisco, California.
This randomized, double blind, placebo controlled, phase 3 study examined a low-dose (3 mg) subcutaneous sumatriptan (DFN-11) administer via autoinjector in the acute treatment of migraines with or without aura in adults.
The first treatment period evaluated the efficacy of DFN-11 by randomly assigning eligible subjects into a test arm receiving a DFN-11 autoinjector (n=104) or a control arm receiving a placebo autoinjector (n=104).
At a moderate to severe pain level during a migraine attack, the study medication was self-administered and post injection pain levels were recorded at specific time point in an eDiary.
The efficacy end point, pain free 2 hours after injection, was significantly higher in the DFN-11 arm vs placebo arm (51.0% vs 30.8%). DFN-11 showed more relief from nausea, photophobia, and phonophobia than the placebo.
The second treatment period evaluated the safety and tolerability of DFN-11 over the next 8 weeks. Injection site pain and swelling were the most common adverse events. Seven subjects withdrew from the study due to these adverse events.
The researchers concluded that DFN-11 “was shown to be effective, well tolerated, and safe in the acute treatment of episodic migraine.”
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Lewis P, Brand-Schieber E, Landy S, Munjal S, Rapoport A. Low-dose (3 Mg) sumatriptan injection (DFN-11) efficacy, tolerability, and safety in episodic migraine: RESTOR, a randomized, double-blind, placebo controlled study. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 449518.