Sprout Pharmaceuticals Continues to Fight FDA over Female Viagra

The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.But a new review released by the Food and Drug Administration shows government scientists still have concerns about whether the drug’s benefits outweigh its risks. The FDA review highlights several safety issues with flibanserin, including low blood pressure and fainting spells. Those problems increased when patients combined the drug with alcohol and some other medications, according to the document. A panel of FDA experts will discuss the drug at a public meeting Thursday, before voting on whether to recommend its approval.

Supporters of Sprout’s drug say women’s sexual disorders have been long overlooked by the FDA. But critics argue that drug development efforts like Sprout’s medicalize women’s sexual problems, which are often related to stress, relationship issues and other life circumstances. The drug’s initial developer, Boehringer Ingelheim, abandoned work on the drug in 2011 and sold it to Sprout, a startup company from Raleigh, North Carolina. Sprout resubmitted the drug with additional effectiveness and safety data, but the FDA again rejected the drug in October 2013. Sprout submitted the drug again after filling a formal dispute over the FDA’s second rejection.

Flibanserin is the first drug to approach the issue through brain chemistry. Originally studied as an antidepressant, the pill was repurposed as a libido treatment after women in company studies reported higher levels of sexual satisfaction. But the FDA has twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea. Clinicians who helped study flibanserin point out that they already prescribe other antidepressants without FDA approval to treat sexual desire disorders. They argue that those drugs, including Wellbutrin and Viibryd, carry worse side effects than flibanserin, such as agitation and seizures.

SEOPrix.com is a professional SEO company in New York, we offers high quality guest post, press release submission, link building, content marketing and more SEO services.

Latest articles

Wearable Breast Pump: Know the five crucial qualities

Doctors strictly recommend mothers to provide their newborn babies with breast milk for the first two years...

Three valuable hiring in China tips to follow

It could be that you have finally decided to start business in China and have completed the...

Which are the best Dunk sneakers in the market?

There are a wide range of sneakers in the market that vary based on their manufacturers, build...

Wire Drawing Dies: Crucial information to know

There are different types of tools and equipment that industries are required to use to enhance their...

Similar articles