Investigational, orally-inhaled therapy effective in treating migraines

Aug 12 2009

A new study conducted at the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania shows an investigational, orally-inhaled therapy is effective in treating migraines.

 The multi-center, phase three FREEDOM-301 trial for the orally-inhaled migraine therapy, LEVADEX™, shows study participants had significant relief from symptoms such as pain, nausea and light and sound sensitivity when compared to placebo treatment. According to trial results, this therapy provided pain relief in 30 minutes and sustained relief for 48 hours after dosing in patients with moderate or severe migraine attacks. The drug was generally very well tolerated and there were no drug-related, serious adverse events reported.

According to the American Headache Society (AHS), migraine is a common, debilitating neurological disorder that affects approximately 30 million people in the United States. The AHS also states that most migraines last between four and 24 hours, but some may last as long as three days. Common associated symptoms of migraine include nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).

“The major advantage of LEVADEX is that it has the efficacy of intravenous DHE (dihydroergotamine) with a side-effect profile similar to placebo and better than oral triptans,” said Stephen Silberstein, M.D., F.A.C.P, a clinical study investigator, director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University.

FREEDOM-301 is a multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of LEVADEX as a potential treatment for acute migraine. Primary efficacy measures include pain relief, and being free from phonophobia, photophobia and nausea at two hours after dosing. Patients enrolled in the trial were evaluated for the treatment of a single moderate or severe migraine attack and then were given the option to continue in an open label, long-term safety study. This safety study is targeting 300 patients for six months and 150 patients for 12 months, and over 500 patients are continuing in this arm of the trial. FREEDOM-301, the first Phase 3 study of LEVADEX therapy, was conducted pursuant to a Special Protocol Assessment with the U.S. Food and Drug Administration. The FREEDOM-301 trial is sponsored by MAP Pharmaceuticals, Inc.

LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using MAP Pharmaceuticals' proprietary TEMPO® inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings for many years to effectively and safely treat migraines. Based on clinical results, MAP Pharmaceuticals believes that LEVADEX has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.

Based on research to date, including the FREEDOM-301 trial, MAP Pharmaceuticals believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.