A potential new obesity drug appears effective at helping patients lose weight, according to a report released today by the U.S. Food and Drug Administration, but concerns remain about side effects — which could include depression, anxiety, impact on heart rate and risks for pregnant women. The document was released in advance of a meeting of an FDA advisory committee meeting scheduled for Thursday, which could open the door toward FDA approval for the drug which would be marketed as Qnexa. As Reuters reports, in spite of the safety concerns, the FDA findings are being embraced by investors — and indeed, the document’s release caused manufacturer Vivus’s shares to jump nearly 20% — as a good sign that the new drug is on the way to approval.
According to the brief prepared for the FDA advisory committee meeting, in trials participants taking Qnexa lost significantly more weight than those taking a placebo, and those taking the highest doses of the drug lost the most weight. As Reuters points out, Vivus recommends that the drug be taken as part of a weight-loss regime that always includes healthy diet and routine exercise.