The drug flibanserin, designed to treat women who have battled sexual dysfunction for decades, hit a road block with the Food and Drug Administration (FDA) advisory panel giving a thumbs-down to the experimental medicine.
The analysts unanimously opposed Germany's Boehringer Ingelheim Pharmaceuticals Inc.'s new drug application flibanserin 100 mg tablet, proposed for treatment of hypo-active sexual desire disorder or (HSDD), saying the risk far outweigh the benefits.
Nevertheless, the panel encouraged the manufacturer to continue its research and come back with more improvements.
U.S. medical director of Boehringer Ingelheim, Christopher Corsico, said, "We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised by the advisory committee. Our ongoing Flibanserin clinical trial program demonstrates our continued commitment to women with HSDD."
Safety of flibanserin in doubt:
Doubts about the safety and efficacy of the drug persist. Experimental studies of flibanserin involving 5,000 women with HSDD indicate the drug helped boost sexual desire only moderately.
In addition, the drug must be taken daily in order to enhance their sexual drive.
ne of every eight women using the drug reported dizziness, nausea, anxiety, fatigue, insomnia and sedation.
The adverse events caused 15 percent of the users to stop taking flibanserin in the clinic trial compared to 7 percent drop-outs in the placebo group.
The researchers found that the side effects were worse when flibanserin was taken in conjunction in other medications, like contraceptives, anti-depressants and anti-fungal treatments.
"It is not clear if labeling alone will be sufficient to alert women to the numerous drug interactions that exist with flibanserin," they wrote.
Filbanserin’s impact on the brain:
Flibanserin "targets a woman's brain chemistry" rather than physically stimulating the body. It was originally developed as an anti-depressant when tested over ten years ago.
Just like all antidepressants, flibanserin impacts levels of serotonin as well as additional chemicals in the brain.
The drug was ineffective at treating depression but scored better as a female sex stimulant in the trials. How it influences sexuality is unclear.
Dr Leonore Tiefer, professor of psychiatry with New York University School of Medicine and Albert Einstein College of Medicine stated, “Since flibanserin is a brain medication, these people keep harping upon this brain point as if all of us understood the neuroscience associated with sexuality, which we do not. This is mythological science.”
Tiefer further explained, “It is actually a medication which impacts serotonin messing around in the brain, yet where? These people have no idea.”
HSDD a controversial medical condition:
Critics argue whether lack of sexual desire is in reality a medical condition or simply a gimmick created by pharmaceutical companies to sell new drugs.
According to sex therapist Dr Dorree Lynn, “The actual issue of whether female sexual desire can be a medical prognosis or whether it can be a life prognosis is likely to be a limitless debate.
“In the event that you have more interconnection with your partner and the capability to maintain communications, desire remains. Advantages come from mastering new skills, from greater intimacy, and also from enhanced communication.”
Source: Boehringer Ingelheim Pharmaceuticals Inc.
