MAP Pharmaceuticals, Inc. announced that the company initiated a pharmacodynamics (PD) trial to compare the acute effect of Levadex orally inhaled migraine therapy to intravenous dihydroergotamine mesylate (IV DHE) and placebo on pulmonary artery pressure as measured by echocardiography. Levadex is a novel orally inhaled migraine therapy that has completed phase 3 efficacy development for the acute treatment of migraine. This trial was initiated in support of a planned New Drug Application (NDA) submission for Levadex to the US Food and Drug Administration (FDA).
In addition to this trial, the company is currently conducting an ongoing 12 month open-label safety extension of its phase 3 FREEDOM-301 trial and a pharmacokinetics (PK) trial in smokers, both of which have completed enrolment. The company anticipates that all patients will complete treatment this year.
"We continue to progress our clinical trials for our NDA submission for Levadex," said Timothy S. Nelson, president and chief executive office of MAP Pharmaceuticals. "The initiation of this PD trial brings us one step closer to our goal of bringing Levadex to many of the approximately 30 million migraine sufferers in the US, including those who are not helped by currently available migraine therapies."
This PD trial is a randomized, double blind, placebo controlled, three way, crossover trial in approximately 24 healthy adults and is designed to compare the acute effects of Levadex, IV DHE, and placebo on pulmonary artery pressure by taking regular echocardiogram measurements over a two hour period. The trial also will compare the PK of Levadex and IV DHE and its metabolites, the effects of both routes of delivery on cardiac function, including echocardiograph findings, 12-lead ECG, and vital signs. In addition, the trial will evaluate the PD and PK of two doses of Levadex administered two hours apart as compared to a single dose of 1.0 mg IV DHE.
Levadex orally inhaled migraine therapy is in phase 3 development for the potential acute treatment of migraine. Patients administer Levadex themselves using the company's proprietary TEMPO inhaler. In the phase 3 FREEDOM-301 trial, Levadex met all four co-primary endpoints at two hours: pain relief (p<0.0001); phonophobia free (p<0.0001); photophobia free (p<0.0001); and nausea free (p=0.02). Levadex was well tolerated and there were no drug related serious adverse events reported in the trial. Data from this phase 3 trial show the potential for Levadex to be effective in treating acute migraine, as well as a broad spectrum of migraine subpopulations that are often difficult to treat with current therapies, including triptans. For example, in this trial, patients with allodynia, menstrually related migraine, migraine with nausea and vomiting, severe migraine or who treated late in their migraine cycle responded well to Levadex .
Levadex is a novel formulation of dihydroergotamine mesylate (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. It is designed to be differentiated from existing migraine treatments. 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 other DHE-based products and other currently available migraine medicines.
MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for patients suffering from conditions that are not adequately treated by currently available medicines.