Shares of MAP Pharmaceuticals soared this morning on news that the company's inhalable migraine therapy Levadex (MAP0004) met all four primary endpoints in a Phase III study. Levadex achieved statistically significant pain relief two hours after treatment, lasting up to 48 hours after taking the drug. Almost 59 percent of patients treated with the drug reported pain relief, compared to just 34.5 percent of those given the placebo. MAP also said that patients reported a statistically significant reduction in sensitivity to sound, light and nausea. There were no drug-related serious adverse events reported in the trial.
"...Levadex showed sustained pain relief for up to two days in this trial with fewer of the side effects generally seen with commonly used migraine treatments," said Shashidhar Kori, M.D., vice president of clinical development and medical affairs of MAP Pharmaceuticals. "We believe that, if these findings are confirmed in a second Phase 3 trial and Levadex is approved for marketing, Levadex could offer significant benefit to many of the 30 million migraine sufferers in the U.S., including many who are not helped by currently available migraine medications." Levadex is delivered by MAP's Tempo inhaler, a technology it's hoping to apply to a number of proven medicines.
In a December interview with FierceBiotech, MAP CEO Tim Nelson noted that Levadex is a product "that would benefit from a partnership," adding that there has been "strong interest" from companies looking to partner on the drug.
- here's the release