“While the FDA still plans to convene a public advisory committee meeting to discuss topics related to obesity drug development in early 2012, it has told Orexigen that the meeting would not impact the advice it provided the company.”
Orexigen Therapeutics and Vivus, two beleaguered California-based developers of obesity drugs, are reporting that talks with the U.S. Food and Drug Administration have helped them establish paths to address concerns the agency raised during separate reviews of their experimental weight-loss drugs in 2010.
If approved, they could play a role in helping the more than one-third of U.S. adults who are considered obese by the Centers for Disease Control and Prevention.
Orexigen’s drug, Contrave, combines the antidepressant Wellbutrin with a sustained-release version of an opioid blocker used to treat alcohol, drug, and other addictions.
The FDA told the San Diego-based company earlier this year that it would not approve the drug without a new large-scale trial to dispel its concerns about the drug’s cardiovascular risks. At the time, Orexigen called the request “unprecedented,” and said that it would generate “significantly more information than is necessary or feasible.” It said it would hold off on further clinical development of Contrave in the United States and explore opportunities for its products abroad.
Since then, the company says it has met with senior officials in the FDA's Office of New Drugs and hashed out the design requirements for a cardiovascular outcomes trial for Contrave that would address the agency’s concerns. Orexigen says that the clinical trial design requirements that arose from that discussion are both “reasonable and feasible” and provide it the certainty it needed to reinitiate development of Contrave.
The company also reports that the FDA told it “if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular risk, the drug could be approved.”
While the FDA still plans to convene a public advisory committee meeting to discuss topics related to obesity drug development in early 2012, it has told Orexigen that the meeting would not impact the advice it provided the company.
Mountain View, California-based Vivus says it too has made progress on getting its obesity drug, Qnexa, closer to approval. Following a recent call with officials of the Endocrine and Metabolic Division of the FDA, the company says it has a plan in hand that would allow for early resubmission of a revised new drug application for Qnexa.
The FDA refused to approve Qnexa in October 2010 citing worries about the potential for the combination drug's components—phentermine and topiramate—to disturb fetal development or cause birth defects.
Vivus says it intends to submit a new application seeking approval for an initial indication that includes obese men and women of non-child bearing potential before the end of October before completing a study assessing the babies of women who were exposed to topiramate during the first trimester of pregnancy in December 2011. A new FDA advisory committee meeting to discuss Qnexa will be held in the first quarter of 2012, the FDA told the company.
September 23, 2011
http://www.burrillreport.com/article-obesity_drugmakers_gain_new_traction_with_fda.html