MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX(TM) orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society. Data from this Phase 3 trial show the potential of LEVADEX to be effective in treating acute migraine as well as a broad spectrum of migraine, including migraine subpopulations that are often resistant to current therapies such as triptans, migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura.
"A majority of patients are dissatisfied with their current migraine treatment due in part to inconsistent response, high rates of recurrence of the migraine attack within 24 hours and slow onset of action," said Stewart Tepper, M.D., Director of Research for the Center for Headache and Pain, Cleveland Clinic. "Based on these Phase 3 data, LEVADEX has the potential to provide rapid and sustained pain relief, along with a favorable tolerability profile. In addition, LEVADEX showed efficacy in a broad spectrum of migraine subpopulations that are often unresponsive to current migraine therapies."
As previously reported, LEVADEX met all four co-primary endpoints, as well as a number of secondary endpoints, in the first of two Phase 3 clinical trials. The four co-primary endpoints at two hours were:
- pain relief (p<0.0001);
- phonophobia free (p<0.0001);
- photophobia free (p<0.0001); and
- nausea free>
Results from the post-hoc analyses reported today found that LEVADEX also was effective compared to placebo in treating migraine:
- in patients with or without allodynia;
- at any time during the migraine attack, regardless of how long patients had waited to treat a migraine;
- that occurs in the early morning, also known as "morning migraine";
- in severely disabled and non disabled patients, as defined by a HIT-6 score;
- with severe as well as moderate intensity of baseline pain;
- with severe intensity of pain, providing pain relief at 10 minutes; and
- with and without nausea, vomiting and aura.
Additional LEVADEX data from the Phase 3 trial showed rapid and sustained efficacy in treating migraine with:
- pain relief at 10 minutes>
- sustained pain relief from two to 24 hours in 44 percent of patients compared to 20 percent for placebo (p<0.0001);
- sustained pain relief from two to 48 hours in 36 percent of patients compared to 17 percent for placebo (p<0.0001, unadjusted for multiplicity); and
- sustained pain free from two to 24 hours in 23 percent of patients compared to 7 percent for placebo, and from two to 48 hours in 18 percent of patients compared to 6 percent for placebo (p<0.0001 for both timepoints, unadjusted for multiplicity).
There were no drug-related serious adverse events reported in the 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 (0 percent), were rare and comparable to placebo. There were no decreases in lung function, as measured by spirometry, between the active and placebo groups.
"These sub-analyses further heighten our enthusiasm for LEVADEX and its potential to help the many patients who suffer from the debilitating effects of migraine, including the potential to provide benefit to a number of significant subpopulations of migraine patients who are not well served by currently available therapies," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "We look forward to continuing development of LEVADEX and initiating a confirmatory Phase 3 trial in the first quarter of 2010."
LEVADEX data are being presented in a late-breaking oral platform presentation titled "LEVADEX(TM), a novel orally inhaled treatment for acute migraine: efficacy and tolerability results of a Phase 3 study" on Saturday, September 12, 2009 at the 14th Congress of the International Headache Society in Philadelphia, PA by clinical trial investigator Stephen Silberstein, M.D., F.A.C.P., director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University. In addition, three poster presentations titled 1) "Efficacy and tolerability of MAP0004, a novel inhaled therapy, in treating acute migraine", 2) "Efficacy evaluation of LEVADEX(TM) (previously MAP0004) in treating resistant migraine including migraine with allodynia, migraine treated late in its cycle, morning migraine and disabling migraine" and 3) "Efficacy evaluation of LEVADEX(TM) (previously MAP0004) in treating a broad spectrum of acute migraine attacks including patients using triptans and patients not using triptans" will be available for review at the conference.