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: