MAP Pharmaceuticals Announces Initiation of LEVADEX(TM) Pharmacokinetics Trial
2010年2月16日 - 9:00PM
PRニュース・ワイアー (英語)
--Trial to be used in support of NDA submission-- MOUNTAIN VIEW,
Calif., Feb. 16 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc.
(NASDAQ:MAPP) today announced that the Company initiated a trial to
compare the pharmacokinetics (PK), safety and metabolic profiles of
LEVADEX(TM) orally inhaled migraine therapy with intravenous
dihydroergotamine mesylate (DHE) in smokers and non-smokers.
LEVADEX is a novel orally inhaled migraine therapy that has
completed Phase 3 efficacy development for the acute treatment of
migraine. This PK trial is one of two remaining trials to be
initiated in support of a New Drug Application (NDA) submission for
LEVADEX as previously requested by the U.S. Food and Drug
Administration (FDA). In addition to the PK trial, the Company is
conducting an ongoing 12 month open-label safety extension of its
Phase 3 FREEDOM-301 trial, which has completed enrollment, and also
plans to conduct a pharmacodynamic trial. The Company anticipates
that patients in these trials will complete treatment in 2010.
"Earlier this year, we announced that a second pivotal efficacy
trial is not required for our NDA submission," said Timothy S.
Nelson, president and chief executive officer of MAP
Pharmaceuticals. "The initiation of this PK trial is an important
step for the Company as we continue to focus on completing our
remaining clinical trials to support our NDA submission for
LEVADEX." This PK trial is a single dose, open-label, crossover
trial designed to compare the PK of LEVADEX to intravenous DHE in
both smokers and non-smokers. The trial includes healthy adult
volunteers, 24 of whom are smokers and 24 of whom are non-smokers.
About LEVADEX(TM) LEVADEX orally inhaled migraine therapy is in
Phase 3 development for the potential acute treatment of migraine.
Patients administer LEVADEX themselves using the Company's
proprietary TEMPO® inhaler. In the Phase 3 FREEDOM-301 trial,
LEVADEX met all four co-primary endpoints at two hours: pain relief
(p