Next Weight Loss Drug on FDA Agenda: Contrave

The Food and Drug Administration (FDA) began reviews this month on three new weight loss drugs. The first to be reviewed, Qnexa developed by Vivus Inc., which is a mixture of two existing drugs, an anticonvulsant (topiramate) and an amphetamine (phentermine). The drug performed well in trials with subjects losing 13 percent and 15 percent of their body weight. However, an FDA advisory committee voted 9-7 to reject Vivus’s application to approve Qnexa, citing concerns over side effects. This leads many to wonder if any of the three drugs will pass muster.

The next drug slated for review by the FDA, in October, is Contrave by Orexigen Therapeutics Inc.  Contrave is also a mixture of an anticonvulsant and an amphetamine but in different dosages. According to Mike Narachi, CEO or Orexigen, Contrave is a combination drug that “targets behavior and reward pathways in the brain.” It combines the antidepressant Wellbutrin (bupropion) with naltrexone, an opioid blocker used to treat alcoholism and opiate addiction. Contrave is designed to address the craving issue that many overeaters experience.

Contrave met all main goals in three different late-stage clinical trials, but also more than satisfied the effectiveness requirement of the Food and Drug Administration (FDA). About 50 percent of patients who took Contrave were shown to lose an average of 5 percent of their body weight over a one-year period. The company said that Contrave also calms food cravings, allowing patients to have better control over their eating.

During the trials, those patients who took Contrave experienced significantly greater weight loss than those who received a placebo. In addition, Contrave reduced other risk factors such as waist circumference, midsection fat and triglycerides, while it improved levels of “good” HDL cholesterol and lowered blood sugar levels in patients with diabetes.