Human trials involving moderate and severe migraine sufferers has shown positive results for treating acute migraine by applying a novel gel on the affected area. The data demonstrated that the simple application of TOPOFEN gel can be a safe and effective alternative treatment for patients suffering from acute migraine.
"Migraine remains a significant global cause of disability and disruption of activities of daily living. The results show promise to provide a safe and effective treatment that will positively impact the disabling effects of such a condition," explained William R. Bauer, migraine headache specialist and advisor to North Carolina-based Achelios Therapeutics that developed the TOPOFEN gel.
The study was conducted by scientists from Achelios and the Michigan Headache and Neurological Institute in Ann Arbor, Michigan. The randomized placebo-controlled study involved 48 adults with a history of episodic migraine. 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.
The trigeminal nerve is a nerve responsible for sensation in the face and motor functions such as biting and chewing.
Compared with placebo, TOPOFEN resulted in greater improvement in pain assessments, 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% experienced relief of pain and migraine-associated symptoms and 45% had sustained pain relief from two to 24 hours compared to 15% of placebo," the authors noted.
Also 50% of patients, who treated their severe pain with TOPOFEN were pain free in 24 hours compared to 25% 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 like nausea versus placebo.
Some patients experienced application-site irritation, predominantly mild or moderate. That was the only reported side effect which resolved quickly.
"The results are encouraging. This study showed that it may be possible to affect severe migraine which can be a debilitating neurological pain condition, with a topical application on skin," added Wolfgang Liedtke from Duke University.
Achelios Therapeutics is set to announce the results at the American Academy of Neurology's annual meeting in Washington on April 22.