On Thursday, the drug industry has made a huge step in its search for producing a female equivalent of Viagra after government specialists recommended the approval of a pill that can boost sexual craving in women.

This is the first time that this kind of authorization is made. This one also came with some safety reservations, and this is due that the pill has side effects that include fainting, low blood pressure, and fatigue.

The voting made by the board of Food and Drug Administration consultants resulted in 18 to 6, favoring Sprout Pharmaceutical’s daily drug, “flibanserin”, with the order of developing a scheme to handle its risks.

The condition imposed to the company doesn’t affect that is a major victory for the pharmaceutical. The drug which is being called as the “female Viagra,” and for years it’s been surrounded by concerns about its safety issues and if it is truly effective.

Since 2010, the FDA has already rejected twice the pills. And five years ago, a similar board of FDA consultants voted against this drug.

Though Thursday’s vote results are not conclusive, the FDA tends to listen the advice of its consultants. Is expected that an official decision will be made in August.

FDA’s specialists recognized that flibanserin’s side effects are weak, and also there’s a need for drugs that can treat female sexual issues that can have the approval of the FDA.

“These are very modest results,” Dr. Julia Heiman of the Kinsey Institute at Indiana University explained. “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”

During the test phase, women who used flibaserin stated that they felt between 0.5 and 1 more sexually satisfactory episodes per month, in comparison with women who take the placebo. On questions related to measuring the level of desire, women who take flibaserin recorded a higher level, as also a lower level of stress.

Flibaserin was originally meant to work as an antidepressant, the pill which work on serotonin and other brain chemicals related to pleasure ended to be repurposed to work as a libido drug after women noticed that their sexual satisfaction had increased.

This project has become the latest effort of the drug industry in addressing women’s sexual issues through the use of brain chemistry, attempting to trigger the sexual interest.

Since the highly acclaimed Pfizer’s Viagra appeared in the market during 1998, many studies and therapies have been focused on the so-called female sexual dysfunction, a term that covers several problems related to orgasm, arousal and libido. These kinds of issues in women have been resilient to drugs that work on blood flow, hormones, and many other biological functions.

Experts showed their concerns about the safety issues with the pill, specifically fainting and low blood pressure. These complications increased in persons who combined flibanserin with alcohol and other common medications, including also antifungal medicines. A research studied how the drug interact with alcohol in a small group of 25 patients.

“We really know almost nothing about the actual clinical effects of using this product together with alcohol,” explained Dr. Tobias Gerhard of Rutgers University. “We have some indication that there is clearly a concern from very small studies.”

Consultants said that the risks of combining the drug with other medicines and alcohol should be appear on the label as a warning sign. According to experts, the Pharmaceutical must educate the prescribers about these issues as also conduct follow-up researches.

Over 30 public spokesmen asked the panel of specialists to support flibanserin, which include different patients from the company’s studies.

“I want to want my husband, it is that simple,” said Amanda Parrish, a mother of four from Nashville Tenn. “For us, flibanserin is a relationship-saving and life-changing drug.”

By the other hand, others have discussed that the FDA has preferred to back therapies for erectile dysfunction drugs for men instead of therapies for women. Different drug-makers, including Sprout Pharmaceuticals, have been in the eye of the claiming that they are part of an insistent lobbying campaign, which is named “Even the Score.”

Sprout’s critics have condemned that lobbying campaign and supporting FDA’s previous negatives.

“To approve this drug would set the worst kind of precedent: that companies that spend enough money can force the FDA to approve useless and dangerous drugs,” explained Dr. Adriane Fugh-Berman of Georgetown University.

If the drug is approved, it would be prescribed for premenopausal women with hypoactive sexual desire disorder, the term used to describe lacking of sexual desire that can cause emotional distress. Before prescribing it, the doctor must rule out different alternate causes. After this they must make a diagnose for the condition, including mood disorders, relationship problems and depression.

Photo Attribution: By The U.S. Food and Drug Administration (FDA Sign & Bldg 21 at Entrance) [Public domain], via Wikimedia Commons

Leave a comment

Your email address will not be published. Required fields are marked *