FDA to decide on Qnexa obesity drug in July

April 10, 2012

US regulators will decide in July whether to approve Qnexa, the first obesity drug in more than a decade, extending the initial deadline by three months, the California-based drug-maker VIVUS said.

The extra time is a "standard extension period" offered by the in order to review additional risk management strategies that were submitted by the company, said a statement issued late Monday.

The new date for a decision is now set for July 17.

An advisory panel to FDA in February urged approval of Qnexa, after warning against its approval in 2010 due to safety concerns.

The panel voted 20-2 that the FDA should allow Qnexa on the market, saying the latest overall benefit-risk assessment supported its approval, but asking for more data on potential risks and how to avoid them.

For instance, some people who took high doses of the drug experienced increased heart rate. When taken by pregnant women it also boosted the risk of having a baby with .

"The Qnexa REMS (risk evaluation and mitigation strategy) submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," said Leland Wilson, of VIVUS.

"We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans."

combines two existing drugs, the appetite suppressant phentermine and topiramate, an anti-convulsant that can be used in conjunction with other drugs for weight loss.

Some doctors already prescribe the combination as an off-label use for helping patients manage their weight.

Studies have shown dieters could lose up to 10% of their weight when taking the drug, along with regular exercise and following a healthy diet.

The FDA does not have to follow the advice of the advisory panel, though it usually does.

Explore further: Experimental drug achieves unprecedented weight loss

Related Stories

Experimental drug achieves unprecedented weight loss

April 11, 2011

An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers ...

FDA panel backs previously rejected obesity pill

February 22, 2012

(AP) -- A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.

Recommended for you

Re-framing the placebo effect and informed consent

October 29, 2015

(Medical Xpress)—Imagine that your doctor knows from evidence-based studies that if he tells you about certain, small side-effects to a particular drug, you are significantly more likely to experience that side effect than ...

Can exercise be replaced with a pill?

October 2, 2015

Everyone knows that exercise improves health, and ongoing research continues to uncover increasingly detailed information on its benefits for metabolism, circulation, and improved functioning of organs such as the heart, ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.