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[Tuff-Stuff]

MOUNTAIN VIEW, Calif. (TheStreet) -- In a review posted to its Web site Tuesday, U.S. drug regulators said Vivus'(VVUS) weight-loss drug Qnexa was effective in helping obese patients shed pounds, but the agency raised questions -- most of them expected -- about the drug's safety.

Vivus shares were up about 34% to $14.25 in Tuesday's pre-market trading session as anxious investors breathed a sigh of relief over the U.S. Food and Drug Administration's relatively benign review of Qnexa, which didn't yield any "Uh Oh!" revelations about the drug's safety.

The FDA will convene an outside panel of experts Thursday to review Vivus' approval application for the weight-loss drug Qnexa. Vivus is trying to become the first company in more than a decade to gain U.S. approval for a new weight-loss drug. Two other companies -- Arena Pharmaceuticals(ARNA) and Orexigen Therapeutics(OREX) -- are fast on its heels.

In the FDA's review of Qnexa, posted online Tuesday as part of the briefing documents for Thursday's advisory panel, pooled data from two large phase III studies demonstrated that patients treated with low, medium and high doses Qnexa lost between 3 percent, 7 percent and 9 percent of their body weight, respectively, adjusted for the weight-loss reported for patients treated with a placebo.

Twenty percent of placebo-treated patients lost more than 5% of their body weight, compared to 45 percent, 62 percent and 69 percent of Qnexa patients.

According to the efficacy criteria laid out by FDA for weight-loss drugs in 2007, the FDA concluded that, "all three doses of PHEN/TPM [Qnexa] were efficacious for weight loss."

Qnexa's safety and not the drug's ability to help patients lose weight, was the major concern entering Thursday's meeting. In its briefing document Tuesday, FDA's safety review highlights five areas of "particular interest" related to Qnexa -- pregnancy risk, psychiatric-related adverse events, cognitive-related adverse events, metabolic acidosis and cardiovascular events.

All of these safety issues had been anticipated by investors as major areas of discussion at Thursday's panel. The FDA chose not to state its own opinion of Qnexa's overall safety in Tuesday's review documents.

Vivus' Qnexa consists of two currently approved drug: The generic weight-loss drug phentermine and topirimate, a drug used to treat epilepsy and migraine, marketed as Topomax by Johnson & Johnson(JNJ).

-- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

[EZ2]

FDA Questions Qnexa Safety

http://www.reuters.com/article/idCNN1323120220100713?rpc=44

Tue Jul 13, 2010 7:07am EDT

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 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.