SAN DIEGO, June 3, 2011 /PRNewswire/ — Orexigen®
Therapeutics, Inc. (Nasdaq:
OREX) announced today that it recently met with the Food and
Drug Administration (FDA) regarding the New Drug Application for
Contrave® (naltrexone HCl/bupropion HCl) extended-release
tablets for the treatment of obesity, including weight loss and
maintenance of weight loss. Orexigen sought the meeting to
gain clarity on the approval deficiency stated in the Complete
Response letter the Company received on January 31, 2011. The
Complete Response letter requested that the Company conduct a
randomized, double-blind, placebo-controlled trial of sufficient
size and duration to demonstrate that the risk of major adverse
cardiovascular events in overweight and obese subjects treated with
Contrave does not adversely affect the drug’s benefit-risk profile.
Orexigen submitted a specific proposal to address the
theoretical cardiovascular risk cited in the approval deficiency
and also explored approval for a narrowed indication in patients
with lower cardiovascular risk until data from the proposed
outcomes trial could be reviewed for label expansion. The
Division of Metabolic and Endocrinologic Products (DMEP) advised
Orexigen that the proposed cardiovascular outcomes trial would not
adequately address the approval deficiency and instead, requested a
pre-approval cardiovascular outcomes trial that Orexigen believes
is unprecedented and would generate significantly more information
than is necessary or feasible. Additionally, DMEP stated that
it would not consider approving Contrave for a narrowed population
without first reviewing data from a cardiovascular outcomes trial.
Finally, DMEP said that it intends to hold a general advisory
committee early next year to discuss cardiovascular assessment for
obesity therapeutics, and that any agreement reached on the
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