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 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.
Orexigen management will host a call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling (866) 730-5771 (domestic) or (857) 350-1595 (international), participant code 27244834. The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
Contrave, an investigational combination therapy of naltrexone HCl and bupropion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients. Orexigen received a Complete Response letter from FDA on January 31, 2011.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Further information about the Company can be found at www.orexigen.com.