FDA Panel Backs Fibanserin, the First Female Libido Drug

[Nelson Vergel]

On Thursday June 4, 2015, the panel of advisers to the U.S. Food and Drug Administration voted 18 to 6 to recommend that the agency approve flibanserin— nicknamed ‘women’s Viagra’ — as the first prescription treatment to boost libido in women. The contingency? That the drug’s manufacturer, Sprout Pharmaceutical, develops measures to limit safety risks. Flibanserin’s risks include low blood pressure and fainting.

“I have serious, serious, serious safety concerns,” said Dr. Walid Gellad of the University of Pittsburgh, a panel member who still voted to recommend approval, reports NBC News. “The benefits are modest, maybe less than modest. But I think that puts it in good company with other approved drugs.”

Flibanserin, a pink pill that would be taken daily at bedtime, would be approved to treat hypoactive sexual desire disorder.

The positive recommendation is a major victory for a drug that’s been twice rejected by the FDA since 2010 due to its minimal benefits and safety concerns.

http://www.dddmag.com/news/2015/06/...?et_cid=4608750&et_rid=449166332&location=top

 

[croaker24]

To me - this is a move where intense lobbying and political pressure organized and funded by the drug manufacturer caused the FDA to cave in on a drug that I do not think is all that effective with some serious safety concerns. If you look at the clinical trials, the results were barely better than the placebo.

Not to mention misrepresentation of the arguments. "Viagra for women"??? Men do *not* have any low-libido drugs. They have drugs to handle ED / vascularity - which does not always mean that libido is improved.

Not to mention the drug appears to me to be nothing more than another type of anti-depressant... it works by raising the dopamine and serotonin levels?

Any big win for greedy Big Pharma and the increasing corruption of the drug approval process.

 

[Nelson Vergel]

The True Significance Of Flibanserin's 'Modest' Boost To Female Sexual Desire

"Most public discussion has focused on the conclusion that flibanserin increases a woman's sexually satisfying experiences by one per month over placebo. In part, that's the easiest way to summarize the 306-page briefing document Sprout released for last week's FDA hearing, and I even used it in my articles.Whitehead says that representation obscures the context in which those increases occurred. In the most recent of three pivotal randomized, double-blind, placebo-controlled trials, women taking flibanserin in a single nighttime dose went from an average of 2.5 sexually satisfying events per month to 5.0 per month. In contrast, women in the placebo group went from 2.7 at baseline to 3.5.

So what the data show is an increase of 2.5 events per month, of which only 0.8 could be credited to placebo.


Consider if we reported instead that women doubled their number of satisfying sexual experiences (from 2.5 to 5.0) and their increase was triple that seen with placebo (increase of 0.8 vs. 2.5). That would also be true. And perhaps the perception of efficacy might be far more positive."

 

[Nelson Vergel]

This is a peptide that some men have used on this site. Palatin Technologies is studying it for improving female libido to compete with Fibanserin.


"Bremelanotide for Female Sexual Dysfunction

Palatin Technologies is developing bremelanotide for female sexual dysfunction, or FSD. Bremelanotide is in Phase 3 clinical trials; to find out more about Palatin's current bremelanotide trials or if the studies are enrolling patients in your area, please visit www.clinicaltrials.gov,www.reconnectstudy.com or email [email protected].

We are developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH. The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual arousal response.
We have completed a Phase 2B clinical trial and meetings with the U.S. Food and Drug Administration (FDA), and started patient enrollment in the Phase 3 clinical trials in December 2014. The Phase 3 studies, which will be conducted in North America, will utilize a single-dose autoinjector intended for commercialization. It is anticipated that the Phase 3 program will take at least fifteen to eighteen months from initiation of patient dosing through database lock. Following database lock, clinical trial data will be analyzed and, assuming the data supports approval of bremelanotide for FSD, a New Drug Application (NDA) will be submitted to FDA."

http://www.palatin.com/products/bremelanotide.asp