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'Headache' Publication Describes Potential Mechanistic Rationale for LEVADEX(TM) Favorable Adverse Event Profile
Date:9/22/2009

MOUNTAIN VIEW, Calif., Sept. 22 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced publication of results from an in vitro study of its novel LEVADEX(TM) (MAP0004) orally inhaled migraine therapy in development exploring the potential mechanism by which the pharmacokinetics (PK) and pharmacodynamics of LEVADEX may produce fewer adverse events than those seen with intravenous dihydroergotamine (DHE). Results will be published in a manuscript titled Reduced Adverse Event Profile of Orally Inhaled DHE (MAP0004) vs IV DHE: Potential Mechanism in an upcoming issue of Headache: The Journal of Head and Face Pain and are available currently in the online version.

LEVADEX, a novel formulation of DHE that is administered via oral inhalation using the company's proprietary TEMPO(R) inhaler, recently met all four primary endpoints in the efficacy portion of a Phase 3 clinical trial. As presented in a late-breaking session at the 14th Congress of the International Headache Society, in the trial LEVADEX provided therapeutic levels of DHE but with lower rates of adverse events, such as dizziness, nausea and paresthesia, than those historically seen with intravenous dosing of DHE.

The in vitro study measured receptor binding and functional activity of DHE at the maximum plasma concentrations (Cmax) achieved in human PK trials after IV administration or after LEVADEX inhalation. The IV DHE Cmax was at least ten times higher than LEVADEX Cmax while the AUCs were approximately the same. The lower LEVADEX Cmax was associated with markedly different receptor binding and functional activity. LEVADEX provided Cmax levels sufficiently high to trigger anti-migraine receptors to the same degree as IV dosing, but did
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SOURCE MAP Pharmaceuticals, Inc.
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