MOUNTAIN VIEW, Calif., April 14 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. today announced additional post-hoc analyses of data from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX(TM) orally inhaled migraine therapy showing efficacy in two difficult to treat patient subpopulations, 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.
As previously reported, LEVADEX met all four co-primary endpoints, as well as a number of secondary endpoints, in the FREEDOM-301 trial. Further analysis of the FREEDOM-301 data showed the potential for LEVADEX to be effective in treating acute migraine as well as a broad spectrum of migraine subpopulations, including migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura. These subpopulations are often difficult to treat with currently available therapies, such as triptans.
"These subanalyses further support our belief that LEVADEX has the potential to help a broad spectrum of migraine subpopulations that are often unresponsive to current migraine therapies," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "With our recent notification from the FDA that a second pivotal efficacy trial will not be required, we are focusing our efforts and resources on our goal of bringing LEVADEX to migraine patients, including these underserved populations."
Findings to be presented today show that in the FREEDOM-301 trial, LEVADEX was effective in treating migraine during a menstrual period. In patients with migraine attacks during a menstrual period:
In a separate subanalysis, LEVADEX was equally effective in treating migraine with and without allodynia and in reversing established allodynia.
There were no drug-related serious adverse events reported in the FREEDOM-301 trial. LEVADEX was well tolerated, with the most common adverse event reported being medication aftertaste at six percent, with two percent of patients receiving placebo also reporting medication aftertaste. The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as chest discomfort (one percent) or chest pain (zero percent), were rare and comparable to placebo. There were no decreases in lung function, as measured by spirometry, between the active and placebo groups. Tolerability in the menstrual migraine and migraine with allodynia subgroups were similar to that in the overall population in the FREEDOM-301 trial.
An additional literature review presented by the Company at AAN reported that many migraineurs experience gastric stasis (slowed digestion) both during and outside of an acute migraine. A non-oral route of administration, such as inhalation, may be preferred in these patients as gastric stasis can slow absorption of oral medications resulting in less timely treatment of a migraine.
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 TEMPO(R) 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, menstrual 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.
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.
Forward-Looking Statements
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to MAP Pharmaceuticals' LEVADEX product candidate. Actual results may differ materially from current expectations based on risks and uncertainties affecting the company's business, including, without limitation, risks and uncertainties relating to the enrollment, conduct and completion of clinical trials, failure to achieve favorable clinical outcomes and to have the company's LEVADEX product candidate approved for commercial use. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Annual Report on Form 10-K for the year ended December 31, 2009, available at http://edgar.sec.gov.
CONTACT: Lisa Borland of MAP Pharmaceuticals, Inc., +1-650-386-3122,
lborland@mappharma.com; or Nicole Foderaro of WCG, +1-415-946-1058,
nfoderaro@wcgworld.com, for MAP Pharmaceuticals, Inc.
Web site: http://www.mappharma.com/
