MAP Pharmaceuticals Resubmits New Drug Application to FDA for
LEVADEX® Orally Inhaled Migraine Drug
MOUNTAIN VIEW, Calif.,
Oct. 16, 2012 /PRNewswire/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced
that it has resubmitted its New Drug Application (NDA) to the
United States Food and Drug Administration (FDA) for LEVADEX®
orally inhaled migraine drug for the potential acute treatment of
migraine in adults.
"We have worked diligently on our LEVADEX resubmission and,
based on our dialogue with the FDA, we believe that we have
addressed the issues outlined by the FDA in the Complete Response
letter we received in March 2012," said Timothy S. Nelson, president and chief executive
officer of MAP Pharmaceuticals. "We continue to dedicate ourselves
to making this potential new treatment for migraine sufferers
available to many of the millions of patients whose migraines are
not well treated with the options available today."
About MAP Pharmaceuticals
MAP Pharmaceuticals is a biopharmaceutical company focused on
developing and commercializing new therapies to address undermet
patient needs in neurology. The Company is developing LEVADEX®, an
orally inhaled investigational drug for the acute treatment of
migraine. The U.S. Food and Drug Administration (FDA) reviewed the
New Drug Application (NDA) for LEVADEX and on March 26, 2012, the Company received a Complete
Response letter with respect to this NDA. MAP Pharmaceuticals has
entered into a collaboration agreement with Allergan, Inc. to
co-promote LEVADEX to neurologists and pain specialists in the U.S.
and Canada. The Company also
applies its proprietary drug particle and inhalation technologies
to generate new pipeline opportunities by enhancing the therapeutic
benefits of proven drugs, while minimizing risk by capitalizing on
their known safety, efficacy and commercialization history.
Additional information about MAP Pharmaceuticals can be found at
http://www.mappharma.com.
CONTACT: Christopher Y. Chai, Sr.
Vice President and Chief Financial Officer of MAP Pharmaceuticals,
Inc., (650) 386-3107; or media, Lisa
Borland, (650) 386-3122, lborland@mappharma.com.
SOURCE MAP Pharmaceuticals, Inc.