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.
NYT article: FSA changes shed light on old eligibility problems
NEW YORK A New York Times report published Tuesday illustrated exactly how far apart the rubber is from the road when it comes to incentivizing preventive healthcare practices and the implementation of the new rules associated with the Patient Protection and Affordable Care Act.
Even as common over-the-counter remedies soon will require a prescription in order to be eligible for reimbursement under flexible spending account arrangements, tried and true preventive healthcare practices, such as breast-feeding, are not and in fact have never been considered eligible for FSA reimbursement, the report noted. “With all the changes the healthcare overhaul will bring in the coming years, it nonetheless will leave those regulations intact when new rules for flexible spending accounts go into effect in January,” the report read.
Breast pumps are not considered eligible FSA expenditures despite the fact that the American Academy of Pediatrics made a direct appeal to the Internal Revenue Service to define such products as breast pumps as a device used for medical care. In May 2009, the IRS determined that breast pumps do not diagnose, cure, mitigate, treat or prevent disease. However, the Food and Drug Administration regulates the manufacture of breast pumps as medical devices, and there are numerous studies that establish the preventive health benefits for children consuming their mother’s breast milk.