WASHINGTON — A topical NSAID gel may be an effective migraine treatment for patients unable to tolerate oral NSAIDs, study results indicate.
Ketoprofen gel (ELS-M11) targets the peripheral trigeminal nerves without the side effects of oral NSAIDs, reported Wolfgang Liedtke, MD, PhD, of Duke University, and colleagues at the American Academy of Neurology 2015 Annual Meeting.
The researchers screened 48 subjects and ultimately enrolled 42 randomized patients in the crossover, double-blind, placebo-controlled study. The patients, mean age 44 and 83% female, had a history of episodic migraine for one year.
During the course of the study, the patients had 130 headache events: 22 patients experienced 49 severe headaches, 22 of which were treated with ELS-M11 and 27 with placebo. The gel was applied facially-bilaterally at all three trigeminal divisions. Of the headaches treated with ELS-M11, 45% had sustained pain relief from two to 24 hours compared to 15% of headaches treated with placebo. At the four-hour mark, 23% of headaches treated with ELS-M11 were pain free compared with 15% of placebo headaches. At 24 hours, 50% of headaches treated with ELS-M11 had pain relief and were pain free compared to 25% of placebo headaches.
Ultimately, patients who treated their headaches with ELS-M11 were three times as likely to experience relief of related headache symptoms such as nausea and photophobia compared with placebo. Adverse effects associated with use of ELS-M11 included irritation at application site, which was predominantly mild or moderate and resolved quickly.
The researchers noted that even after 24 hours, the drug does not lose efficacy because efficacy is based on the amount accumulated in the tissue rather than what’s circulating in the blood.
Based on the results, which were more profound in patients with severe headaches compared to those with mild attacks, the researchers now plan to conduct phase 2b and 3 studies to better determine efficacy and explore the mechanism further.
Disclosure: The study was funded by Achelios Therapeutics.
- Liedtke W et al. Topically Applied Ketoprofen Gel (ELS-M11) in the Treatment of Severe Migraine Pain. Emerging Science 013. Presented at: American Academy of Neurology Annual Meeting 2015; April 18-25, 2015. Washington, D.C.