A migraine drug from
provided significant relief from headache pain and other symptoms, according to results from a phase III study released Tuesday.
The Mountain View, Calif.-based drugmaker is developing the migraine drug, known as Levadex, on its own, although MAP is expected to seek out a larger drug company as a partner based on the positive results from this first of two planned phase III studies.
Levadex is an inhaled form of dihydroergotamine (DHE), a drug used intravenously to treat migraines. Migraine sufferers breathe Levadex into their lungs using MAP's proprietary inhaler.
MAP said according to the results of the phase III study 59% of migraine sufferers treated with Levadex were pain free after two hours compared with 35% patients treated with a placebo. The result was statistically significant.
Levadex also demonstrated a statistically significant improvement over placebo for sensitivity to light and sound as well as nausea reduction. Pain relief set in over 30 minutes and continued for up to two days.
The phase III study enrolled 792 migraine headache patients, with 46% of patients reporting severe pain and 54% reporting moderate pain prior to treatment.
Levadex was well tolerated, with 6% of patients reporting medication after taste as the most common adverse event, according to MAP.
"We are very pleased with these results and look forward to continuing development of Levadex with the goal of bringing this differentiated therapy to the many patients who suffer from the debilitating effects of migraine," said Timothy Nelson, MAP's CEO, in a statement.
"Market research has shown that migraine patients want medications that can treat all symptoms of their migraine rapidly and that are long-lasting as well as convenient to take. Unlike currently available migraine therapies, we believe that Levadex has the potential to address all these patient needs and to offer a significant advancement in migraine therapy for this underserved patient population," he added.
received recent approval for a new migraine drug called Treximet, aimed at replacing Glaxo's popular but now genericized drug Imitrex.
MAP Pharmaceuticals specializes in developing improved versions of existing drugs. The company's stock price took a severe hit in February on negative phase III study results for a drug to treat pediatric asthma, being developed in partnership with
. Levadex is the company's second late-stage drug candidate.
MAP shares closed Friday at $3.15.
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