Sexual HealthMAP Pharmaceuticals Phase 3 Trial Of Levadex™ Migraine Product Candidate Meets All Four Primary Endpoints
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX™ orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.
Patients taking LEVADEX therapy (formerly referred to as MAP0004) had statistically significant improvement at two hours compared to patients on placebo for each of the primary endpoints:
- Pain relief: 58.7 percent of patients who received LEVADEX compared with 34.5 percent for placebo (pFREEDOM-301 Trial Design
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 phonophobia, photophobia and nausea free at two hours after dosing. 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.
A total of 792 patients (ages 18 to 65) were included in the modified intent to treat population used for primary data analysis, as specified in the protocol. Patients enrolled in the trial were evaluated for the treatment of a single moderate or severe migraine, and then were given the option to continue in an open label, long-term safety arm. This safety arm 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.
About LEVADEX™
LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 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 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 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.
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 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.
About Migraine
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 1.5 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