MOUNTAIN VIEW, Calif., April 7 MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced the Company will present additional post-hoc analyses from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX(TM) orally inhaled migraine therapy in two patient subpopulations that are often difficult to treat with current triptan migraine therapies: menstrual migraine and migraine with allodynia. The data will be presented at the Annual Meeting of the American Academy of Neurology (AAN) in Toronto, Ontario on Wednesday, April 14, 2010. A summary of the company's AAN presentations is below and the abstracts can be accessed at the AAN website at www.aan.com.
Advertisement
About LEVADEX(TM)
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 TEMPOŽ 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.
Advertisement
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.
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, and 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.
About MAP Pharmaceuticals
MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for patients suffering from conditions that are not adequately treated by currently available medicines. The company is developing LEVADEX inhaled therapy for the potential treatment of migraine and has reported positive results from the efficacy portion of its Phase 3 trial of LEVADEX. In addition, MAP Pharmaceuticals generates new pipeline opportunities by applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history.
Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com.
Evaluation of Safety and Efficacy of MAP0004 in Treating Acute Menstrual Migraine Session Info: Scientific Sessions: Headache II, 4:15-5:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 4:30 p.m. ET Presentation #: S35.002 Evaluation of Efficacy and Safety of MAP0004 in Reversing Central Sensitization and Treating Migraine in Established Allodynic Patients Session Info: Poster Session IV: Headache and Facial Pain, 3:00-7:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 3:00 p.m. ET Poster #: P04.007 The Timing of Gastric Stasis in an Acute Migraine and its Impact on Treatment Session Info: Poster Session IV: Headache and Facial Pain, 3:00-7:30 p.m. ET Presentation Info: Wednesday, April 14, 2010 at 3:00 p.m. ET Poster #: P04.008
SOURCE MAP Pharmaceuticals, Inc.
