MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX. At this time, all patients have been enrolled in the Company's clinical trials in support of an NDA, which the Company expects to submit in the first half of 2011.  LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

The Company also gave an update of its LEVADEX clinical development program:

  • Open-label safety trial: To date, more than 400 patients have completed at least six months of treatment and more than 200 patients have completed twelve months of treatment. All non-asthmatic patients and a subset of asthmatic patients have completed treatment.  The remaining patients are expected to complete treatment in 2010.  The Company and an independent data monitoring committee (DMC) recently completed an interim safety review of all patients, including asthmatics. In this trial, LEVADEX has been well tolerated and no drug-related serious adverse events have been reported. To date, no clinically significant trends have been reported for LEVADEX in the evaluation of cardiovascular measurements (as measured by electrocardiogram, echocardiogram and chest x-ray) and pulmonary function (as measured by DLco and FEV1). This 12 month open-label, long- term safety extension of the Company's Phase 3 FREEDOM-301 trial is designed to evaluate overall safety of LEVADEX in at least 300 patients for six months and 150 patients for 12 months, including asthmatics.  
  • Thorough QT trial: The Company has completed treatment in a randomized, double-blind, placebo controlled, three-way, crossover trial in approximately 54 healthy adults that will evaluate whether LEVADEX has an effect on QT interval as measured by electrocardiogram. The objectives of the trial are to compare the acute effect of LEVADEX, moxifloxacin and placebo on the QT interval and assess the tolerability of a supratherapeutic dose of LEVADEX. The Company anticipates releasing results from this trial in the fourth quarter of 2010.  
  • Pharmacodynamics (PD) trial:  This completed trial showed that there was no statistically significant difference between the LEVADEX orally inhaled migraine therapy and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration.  Pulmonary artery pressure in the IV DHE group was higher than both the LEVADEX and placebo groups. The PD trial was a randomized, double blind, placebo controlled, three-way, crossover trial in healthy adults, comparing the acute effects of LEVADEX, IV DHE and placebo on pulmonary artery pressure.
  • Pharmacokinetics (PK) trial: This completed trial showed that the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers. This single dose, open-label, crossover trial compared the PK of LEVADEX to intravenous DHE (IV DHE) in both smokers and non-smokers.
Source:

MAP Pharmaceuticals, Inc.

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