Potential migraine therapy to be presented April 22 by Achelios Therapeutics
Achelios Therapeutics will announce results from a Phase IIa placebo-controlled clinical trial in moderate and severe migraine sufferers treated with TOPOFEN (TM), the company's proprietary topical anti-migraine therapy. The data to be presented demonstrate that the simple application of a well-known non-steroidal anti-inflammatory drug (NSAID), using the company's proprietary formulation on the skin, over the trigeminal nerve branches, can be a safe and effective alternative treatment for patients suffering from acute migraine.
William R. Bauer, M.D., Ph.D., FAAN, a neurologist and migraine headache specialist and advisor to Achelios, said, "Migraine remains a significant global cause of disability and disruption of activities of daily living. TOPOFEN results show promise to provide a safe and effective treatment that will positively impact the disabling effects of such a condition."
The results of the clinical trial will be presented at the Emerging Science session of the American Academy of Neurology annual meeting in Washington, D.C., on Wednesday, April 22. The study was conducted by scientists from Achelios and the Michigan Headache & Neurological Institute in Ann Arbor, Mich.
Wolfgang Liedtke, M.D., Ph.D., from Duke University will present the results as a member of the team that conducted the research and a paid advisor to Achelios. Liedtke, an associate professor of neurology and attending physician in the Duke Pain Medicine clinics, said, "The results of the study are encouraging, and those of us who treat migraine think it may lead to a meaningful alternative treatment for a substantial number of migraineurs. This study showed that it may be possible to affect severe migraine, which can be a debilitating neurological pain condition, with a topical application to facial trigeminal nerve endings, which was unexpected."
Crist Frangakis, Ph.D., president and CEO of Achelios Therapeutics, the study sponsor, said, "The positive results of this study provide preliminary evidence that migraines can be effectively treated topically without the safety and side effects challenges that often accompany systemic oral medications. Serious side effects of NSAIDs, such as stomach bleeding and ulcers, result in more than 100,000 hospitalizations and thousands of deaths each year in the U.S. With TOPOFEN physicians and patients, especially those with cardiovascular risks, will have a new treatment option."
The randomized, crossover, double-blind, placebo-controlled study involved 48 screened adults with a history of episodic migraine with and without aura (the warning signs that can precede headache pain in about 20 percent of sufferers). Patients were instructed to treat five moderate to severe migraines by applying the TOPOFEN gel on the skin, over the three branches of the trigeminal nerve, and to record their symptoms on an electronic diary.
Compared with placebo, TOPOFEN resulted in greater improvement in pain assessments after study drug application, a faster time to pain response, a reduction of migraine-associated symptoms such as nausea, light and sound hypersensitivity, and greater suppression of pain over the 24-hour period that patients were asked to follow each migraine once they applied the gel.
Of the severe migraine patients, 77 percent experienced relief of pain and migraine-associated symptoms and 45 percent had sustained pain relief from two to 24 hours compared to 15 percent of placebo. Also 50 percent of patients who treated their severe pain with TOPOFEN were pain free at 24 hours compared to 25 percent of placebo-treated patients. Patients whose severe headaches were treated with TOPOFEN were at least three times as likely to experience complete relief of associated symptoms (nausea and photophobia) versus placebo. Some patients experienced application-site irritation, predominantly mild or moderate. That was the only reported side effect, which resolved quickly.
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