MAP Pharmaceuticals, Inc. announced completion of the Levadex open-label safety trial. The company has now completed the final trial necessary to support a New Drug Application (NDA) for Levadex and plans to submit an NDA in the first half of 2011. Levadex is a novel orally inhaled migraine therapy that has completed phase III clinical development for the acute treatment of migraine.
“We are pleased to have completed the Levadex clinical program. This clinical trial completes a comprehensive 505(b) (2) clinical development program which evaluated the efficacy, safety, pharmacokinetics and pharmacodynamics of Levadex in approximately 1,000 patients,” said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. “In 2010, we announced that a second phase III trial would not be necessary for our NDA submission, completed and announced successful results from a pharmacokinetics trial in smokers, a pharmacodynamics trial evaluating pulmonary artery pressure and a thorough QT trial, and we have now completed our open-label safety trial.”
The 12 month open-label, safety extension of the phase III Freedom-301 trial was designed to evaluate overall safety of Levadex over six and 12 months of exposure. In total, more than 475 patients completed six months treatment and more than 250 patients completed 12 months treatment. In this trial no drug-related serious adverse events were reported.
The company anticipates presenting safety results from the trial at an upcoming scientific conference.
Levadex orally inhaled migraine therapy is a novel migraine therapy in phase III development. Patients administer Levadex themselves using the company's proprietary Tempo inhaler. Levadex has been designed to be differentiated from existing migraine treatments. It is a novel, preservative-free formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that Levadex has the potential to provide fast onset of action, sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.
Levadex is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the efficacy portion of the Freedom-301 trial, the company 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.
Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). According to the National Headache Foundation, most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1 to 3 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly, according to published studies. Migraine patients report that currently approved drugs do not fully meet their needs due to slow onset of action, short duration of effect, inconsistent response and unacceptable side effect profiles. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.
MAP Pharmaceuticals is an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology. The company is developing Levadex orally inhaled therapy for the potential treatment of migraine and has reported positive results from the efficacy portion of its phase III trial of Levadex.