Follow
FDA advisory panels finally recommended the approval of Flibanserin drug, also known as the Viagra for women drug or the pink pill.
In an unequal market development that targets sexual dysfunctions treatment, dominated by drugs that treat male sexual dysfunction, Flibanserin comes to tilt the balance. After long debates within the FDA, now the U.S. drug market will see the introduction of Flibanserin after a much welcome vote of 18 to 6 approved the new drug for the female segment of the population.
The approval does come with warning signs and strict regulatory conditions.
What Flibanserin does is that it alters the levels of hormones such as serotonin and dopamine in order to increase women’s libido. Great advocacy efforts have been seen in relation to the approval of this drug.
Nonetheless, at this point, even with the FDA’s approval, physicians are still urged to closely monitor possible side effects with their patients that are starting treatment with Flibanserin. It is necessary to monitor side effects that might include dizziness, vomiting or nausea.
Viagra for women or the pink pill targets specifically women in their premenopausal period. A physician will only prescribe it to patients who have been diagnosed with hypoactive libido. While it is acknowledged that the pink pill has significant effects on fighting decreased sexual desire, the FDA is concerned about its safety levels.
Flibanserin is a drug developed by Sprout Pharmaceuticals and has undergone numerous clinical trials until now. However, the FDA rejected it two times since its development was announced.
In 2010, the agency decided that the effects Flibanserin has on women’s libido were not sufficiently researched. In 2013, the FDA rejected the pink pill once more on similar reasons, claiming that the researched effects on increasing sexual desire in women were modest at best.
Attached to these concerns repeatedly voiced by the FDA, there was a vast debate on the side effects of the pink pill. In contrast to the modes effects on increasing women’s libido, the drug seemed to point to rather alarming side effects and insufficiently researched interaction with other drugs.
Now, the positive approval vote of the FDA still requires guarantees that Viagra for women is as safe as its producers make it sound.
A nationwide debate has surrounded Flibanserin and its being the first drug that fights female sexual dysfunction. Two definite sides to the story were claiming either that this is not a real medical condition for women and therefore no drugs are needed, or that the FDA and the pharma industry is gender biased.
Following the rejections of the FDA and in an intense lobbying effort, Sprout Pharmaceuticals joined the online campaign fighting for the approval of Flibanserin, titled “Even the Score”. Other pharma representative, as well as advocacy groups joined their efforts in exerting pressure on the FDA.
Two years later it seems that their efforts were successful. Flibanserin is on the market, albeit strict medical supervision required by the FDA.
Image Source: medicaldaily.com
