FDA
5th June 2015

FDA Panel Supports Approval of ‘Female Viagra’ (Flibanserin)

Yesterday, in a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug.

FDA Panel Supports Approval of ‘Female Viagra’ (Flibanserin)

Yesterday, in a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panelists voted 18-6 in favor of approval of flibanserin (Sprout Pharmaceuticals) for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The materials for this meeting can be found HERE.

Flibanserin is a 5-HT1A receptor agonist and 5-HT2A receptor antagonist. Flibanserin is a non-hormonal treatment, and works by balancing neurotransmitter activity that supports a healthy sexual response.

Interestingly, Thursday’s meeting was the third time the FDA has reviewed flibanserin. Prior reviews by the FDA had given the drug a negative outlook, noting that there were several side effects and no noticeable benefit. In 2010, a committee told Boehringer Ingelheim, the initial drug-makers of flibanserin,that the company should go back to the drawing board to gather more conclusive data about the drug’s efficacy and safety. In 2013, the drug was rejected without going before the committee.

A more recent 2013 study demonstrated that women taking the drug reported an average increase of 2.5 satisfying sexual events in four weeks, compared with an increase of 1.5 among women using a placebo.

Despite the drug being dubbed “Viagra for women,” experts say that it is inappropriate to describe flibanserin in such a manner as the two drugs have drastically different mechanisms of action. Flibanserin works through the brain, while viagra works on the body, essentially treating erectile dysfunction but doing nothing to induce sexual desire.

In addition, experts explain that for women, the cure for low libido is more likely to be found in their brains than in a bottle.

“Women’s sexuality is very complicated. It’s not a matter of just taking that pill by the way, and then all of a sudden the lights go on,” stated Judy Kuriansky, a clinical psychologist and certified sex therapist. “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. … It’s complex. It’s not the same as a man taking a pill.”

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you have an upcoming Advisory Committee Meeting?

White Oak Gude

 

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us