Biopharmaceutical company Vivus, Inc. (VVUS) failed to get U.S. Food and Drug Administration approval for its obesity drug Qnexa Controlled-Release Capsules. The company Thursday said it received a Complete Response Letter, or CRL, from the FDA regarding its New Drug Application for Qnexa, communicating that the application cannot be approved in its present form.
Qnexa, a controlled-release formulation of two drugs - Phentermine and Topiramate, becomes the second weight loss drug recently rejected by the FDA on safety concerns. Last week, the agency declined to approve Arena Pharmaceuticals Inc. (ARNA)'s lorcaserin on safety concerns. Earlier this month, it forced Abbott Laboratories (ABT) to pull out its weight-loss drug Meridia from the US market after 13 years, citing the risk of heart attacks and strokes for certain patients.
Vivus' NDA for Qnexa sought approval to market the drug as an oral, once-a-day formulation for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. The FDA has requested additional details on clinical, labeling, REMS, safety update, and drug scheduling related to Qnexa.
The regulators asked Mountain View, California-based Vivus to evaluate and mitigate the potential teratogenic, an agent that can disturb the development of the embryo or fetus, risks in women, and also asked to assess heart risks of the medicine. The agency also requested a safety update of any new adverse events be submitted to the NDA. In July, a federal advisory committee turned down Qnexa due to safety concerns.
Vivus has also been asked to submit the results from the already completed Sequel study of the drug. The company announced top-line results from the two-year Sequel study last month and a final study report is being prepared for submission to the NDA.
The FDA stated that if approved, Qnexa would be a Schedule IV drug, a category of drugs that have less potential for abuse or addiction than those of Schedules I to 3, due to the phentermine component. The company said no new clinical studies were requested in the CRL, however, in the event that any of the FDA concerns are not alleviated, additional clinical studies may be required.
Vivus said, as part of the written response, it plans to compile analysis integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of the drug, cardiovascular risks. The company said it is preparing a comprehensive response to the CRL and plans to submit to the FDA in around six weeks.
Vivus' Chief Executive Leland Wilson said, "We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity."
Orexigen Therapeutics Inc. (OREX), another player in this field, is awaiting FDA panel review of its NDA for obesity drug Contrave, which is scheduled for December 7.
In Thursday's regular trading session, VVUS closed trading at $6.13 per share on the Nasdaq.
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