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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 design of a cardiovascular outcomes trial would be subject to change following DMEP's interpretation of the input received at the 2012 advisory committee.
Based on DMEP's feedback, Orexigen plans to:
appeal DMEP's responses through the formal dispute resolution process;
put on hold any further clinical development for its obesity programs in the United States until a clear and feasible path to regulatory approval is identified; and
accelerate the exploration of opportunities for our product candidates outside of the United States.
"The Orexigen team has been working for the last several months with leading experts in the field of cardiovascular outcome trials to develop and submit a proposal to DMEP that we believe would more than adequately address the question of theoretical CV risk," said
Michael Narachi, CEO of Orexigen. "We remain very disappointed in the stance of DMEP and the outcome of the recent meeting. We have serious concerns about the broader implications these actions may have on innovation in the obesity space and the availability of much needed treatment options for obese patients in the U.S."
Since receiving the Complete Response, Orexigen has been evaluating other opportunities where it can leverage its management team, cash and other resources. With the result of this recent meeting, Orexigen plans to advance its evaluation of new opportunities.