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Home » Long Term Weight Loss » UPDATE 2-Vivus obesity drug has safety risks-US FDA staff

* Qnexa drug helped patients lose weight - FDA staff

* Vivus (Xetra: 893380 - news) shares up more than 5 pct

* Qnexa tied to heart, memory problems

* FDA staff say long-term safety with Qnexa unknown (Adds details from FDA review, context on obesity drugs)

Feb 17 (Reuters) - Vivus Inc's Qnexa helped people lose weight but may cause long-term health problems, U.S. drug reviewers said in their first assessment of an obesity drug after a series of high-profile rejections in recent years.

Food and Drug Administration staff will ask an advisory panel next week to consider whether Qnexa's benefits for obese patients outweigh its risk of birth defects and heart problems, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug in 13 years.

The FDA rejected Qnexa in 2010 because of safety problems, and in documents posted online on Friday, still seemed skeptical about the drug's long-term health effects, especially on the heart.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said.

The FDA staff said they would ask an advisory panel on Wednesday whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision on the drug by April 17.

Shares of Vivus rose 5.2 percent to $11.76 in morning trading on Nasdaq (Nasdaq: ^NDX - news) .

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

REAL-WORLD PROBLEMS

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

But in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women managed to get pregnant during the clinical trial.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.

Vivus is not the only company vying to get an obesity drug on the market.

Arena Pharmaceuticals (NasdaqGM: ARNA - news) and Orexigen Therapeutics have been pitching their own fat-fighters to the FDA, but like Vivus, have faced rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.

The FDA is also set to review Arena (Milan: ARE.MI - news) 's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug approved for long-term use is Roche Holding AG's Xenical, which gained approval in 1999. GlaxoSmithKline (Other OTC: GLAXF.PK - news) markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas. (Reporting by Anna Yukhananov; Editing by Derek Caney, Steve Orlofsky and Lisa Von Ahn)

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UPDATE 2-Vivus obesity drug has safety risks-US FDA staff

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Home » Long Term Weight Loss » UPDATE 2-Vivus obesity drug has safety risks-US FDA staff