FDA declines to approve Qnexa
MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.
The company said Thursday that it received a complete response letter from the FDA for Qnexa (phentermine and topiramate) controlled-release capsules. The agency said the application can’t be approved in its current form and asked for additional study data. The FDA issues a complete response letter to indicate that it has completed review of an application, but questions remain that preclude final approval.
The prospects for the drug’s approval didn’t look good even before Vivus submitted its application, despite the drug showing some promise in clinical trials. In July, an FDA advisory committee voted 10-6 against recommending approval for Qnexa, citing such possible side effects as psychiatric problems and birth defects. Though an advisory committee’s vote does not determine whether the agency will approve a drug, its vote is taken into consideration.
Symposium addresses sexual dysfunction among women
NEW YORK Sexual dysfunction often is conceived as a male phenomenon, but it frequently affects women as well, and for a wide variety of reasons.
Such disease states as cardiovascular disease, diabetes and thyroid disease; drugs ranging from NSAID painkillers to narcotics to psychiatric medications; and even such conditions as stress and ADHD can all contribute to sexual dysfunction in women. But female sexual dysfunction often goes unmentioned, even though it may affect up to 50% of women, according to a 2003 Austrian study published in the journal Urology. Yet according to Semprae Labs, 90% of the women affected by female sexual dysfunction are reluctant to talk about it.
“We seem to be very uncomfortable,” Mary Jaensch, CEO of Semprae, said at a symposium for members of the press Thursday morning. The symposium, at New York’s Penn Club, was to promote Zestra essential arousal oils, an over-the-counter topical botanical product designed to stimulate sexual arousal in women. The symposium included such experts as Susan Kellogg, director of sexual medicine at the Pelvic and Sexual Health Institute of Philadelphia, and relationship experts Tamsen Fadal and Matt Titus.
“All women deserve sexual satisfaction,” Kellogg said at the symposium.
GSK Consumer Healthcare applauds FDA’s workshop on NRT products
PARSIPPANY, N.J. GlaxoSmithKline Consumer Healthcare on Thursday commended the Food and Drug Administration for holding a scientific workshop this week that focused on the risks and benefits associated with the long-term use of nicotine-replacement therapy products.
GSK, the manufacturer of smoking-cessation products NicoDerm and Nicorette, suggested the workshop is a first step in supporting language in the 2009 Family Smoking Prevention and Tobacco Control Act, which called upon the FDA to "consider approving the extended use of nicotine-replacement products — such as nicotine patches, nicotine gum and nicotine lozenge — for the treatment of tobacco dependence."
As a result of the FDA’s review of long-term use, GSK has submitted a statement into the FDA public docket on its position regarding the long-term use of NRT. GSK believes that using NRT products to quit smoking is far safer than continuing to smoke. NRT products offer a step-down therapy that doubles a smoker’s chances of quitting versus attempting to quit smoking “cold turkey.” Additionally, several other countries already encourage the use of NRT products for longer durations to keep people tobacco-free.
Smoking is the No. 1 preventable cause of disease and death in the United States. More than 46 million Americans smoke. Research indicated about 70% of smokers want to quit at any given time, but the success rates remain suboptimal. Tobacco use causes more than 400,000 deaths in the United States each year, and approximately 8.6 million Americans have chronic illnesses related to smoking.