WASHINGTON, July 13 (Reuters) - Vivus Inc's (VVUS) experimental obesity pill appears to help people shed pounds, but concerns remain about its safety, U.S. Food and Drug Administration staff said in documents made public on Tuesday ahead of a public meeting on the drug later this week.
The biotechnology company wants to market its once-a-day pill, Qnexa, for use with diet and exercise. If approved, it would be the first new U.S. prescription weight-loss drug in a decade.
Anticipation of a potential new obesity drug in a nation where more than two-thirds of the people are overweight has rocked the drugmaker's shares for more than a year as anxious investors anticipate the FDA's decision.
Shares of Mountain View, California-based Vivus were up 4.5 percent at $11.13 in trading before the market opened. The stock has more than doubled over the last 12 months.
All three doses of the drug "were efficacious for weight loss," FDA staff reviewers said, but there are five areas of safety concerns, including the effect on pregnant women and psychiatric side effects such as depression.
There were also more reports of attention span, memory and language problems as well as of increased heart rate in Qnexa patients, the staff said in documents posted on the FDA's website[#msg-52211105]. The potential for increased body acids was also a concern.
On Thursday, an FDA panel of outside experts will discuss the safety issues and offer advice on whether to approve Qnexa. The agency will make the final approval decision, which Vivus expects by Oct. 28.
Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX) are also seeking FDA approval for their rival obesity pills, which face FDA panel reviews later this year.‹
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