MAP Pharmaceuticals to Present Data From LEVADEXÃ‚® Pharmacokinetics and Pharmacodynamics Safety Studies at the 63rd Annual Meeting of the American Academy of Neurology
MOUNTAIN VIEW, Calif., April 12, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) today announced that the Company will present new data from two safety studies of LEVADEX® orally inhaled migraine drug. The data will be presented at the 63rd Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii April 9-16, 2011. LEVADEX is an investigational acute drug for migraine that has completed Phase 3 clinical development.
Findings to be presented at 2:00 p.m. HAST today in the poster titled "An Open-Label, 2-Period, Crossover Study Comparing the Pharmacokinetics and Tolerability of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE (DHE45) in Smoking and Non-Smoking Adult Volunteers," show that:LEVADEX exposure was not higher in smokers, potentially due to reduced pulmonary absorption LEVADEX was quickly absorbed into the bloodstream of both smokers and non-smokers, as evidenced by a median Tmax of 4.98 and 7.02 minutes respectively The mean half-life for LEVADEX was similar for smokers (16.1 hours) and non-smokers (14.5 hours) and was similar to IV DHE administration (13.3 hours for smokers and 12.4 hours for non-smokers) Tolerability of LEVADEX was similar in smokers and non-smokers
Findings in a separate safety study to be presented at 2:00 p.m. HAST today in the poster titled "A Randomized, Double-Blind, Placebo Controlled, Three-Period Crossover Study Comparing the Acute Effects of LEVADEX (MAP0004, Orally Inhaled DHE) and Intravenous DHE on Pulmonary Arterial Systolic Pressure," show that:Neither LEVADEX, IV DHE nor placebo produced clinically significant changes in pulmonary arterial systolic pressure (PASP) or other cardiac functions; however a statistically higher elevation of PASP was found following IV DHE treatment compared to the LEVADEX and placebo tr