Raleigh Company Sold Days After Female Libido Drug Approval
This has prompted the FDA to require the drug’s manufacturer to include a strong “boxed warning” to notify patients who drink alcohol and have liver problems not to take Addyi.
The pink pill – formerly known by its generic name, flibanserin – will hit pharmacy shelves on October. 17 and will be comparable in price to Viagra, the blockbuster pill that helps men get and maintain erections. In fact, it was originally studied as a treatment for depression before being repurposed into a libido drug. It particularly changes how brain cells respond to various message carrying chemicals called neurotransmitters, thereby improving a woman’s sexual drive over time.
Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. The supporters questioned whether the FDA’s previous rejections of the drug resulted from gender bias. Snag is, the drug isn’t very effective, has bad side effects and regulatory restrictions may crimp sales. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections. Spout Pharmaceuticals, the company that produce the drug, said that women experienced an increase “in the number of satisfying sexual events” in trials but experts believe results were limited. Many psychologists say there are often many factors that affect sexual appetite, including relationship issues, depression, stress and mood disorders.
It also carries significant adverse effects. The multi-national Valeant, which is based in Quebec and also owns Bausch + Lomb, said it will pay Sprout a share of future profits based on certain milestones.
According to reports, a drug named “female Viagra” has been approved by the U.S. FDA body this week.
Since then, Sprout conducted another study of sexual desire using a different method that achieved statistical significance.
The FDA rejected two prior versions of Flibanserin and the approved Addyi can cause low blood pressure, dizziness and fainting.
Nonetheless, Addyi is the first and only drug treating HSDD on the market, and the massive social-media campaign that backed its approval indicates a substantial demand for some kind of libido drug. But the company gave no hint of plans to sell the drug to a larger company.