Sprout Pharmaceuticals Is Close To Obtaining FDA Approval On The First Drug Available For Women Suffering HSDD
The FDA (Food and Drug Administration) met jointly with the Bone, Reproductive and Urologic Drugs Advisory Committee and also the Drug Safety and Risk Management Advisory Committee to decide with an eighteen to six vote that Sprouts Pharmaceuticals ADDYI meets approval of FDA guidelines with their Hypoactive Sexual Desire Disorder (HSDD) for women in premenopausal. A stipulation was set stating only if certain options for risk management apart from labeling are used.
Sprout Pharmaceuticals is very excited about this outcome. They are now one step closer to being able to get their product out to the public for one of the most common female sexual dysfunctions. HSDD is a sexual dysfunction in women that has been recognized by the medical community for over 40 years. This disorder is defined as having a lack of desire for sexual activity. This results in the decline of women’s personal relationships. There are approximately one in three women who suffer from HSDD in the United States and one in ten who are distressed by its affects.
ADDYI is one of the most studied health products in history. This medication continued to demonstrate significant results over placebo tests on three key points.
* Increase in sexual desire
* Decrease in distress as the sexual desire returned
* Increase in the frequency of satisfying sexual activity
The improvements were seen in as little as four weeks and were maintained over the 24 week treatment time. The women included in the testing, agreed themselves that the improvements they experienced were meaningful to them.
ADDYI was tested in clinical trials in over 8,500 patients. Of the 8,500 patients, 1,000 of them used the treatment for about a year. The safety profile it created was favorable. The side effects experienced in some of the test patients included; sleepiness, nausea and dizziness. The FDA is still not required to accept ADDYI and apply their approval to it even though the joint meeting did end in favorable results. They are still considering this new drug and if approved it will be the first on the market with FDA approval for HSDD.
ADDYI is designed to help restore prefrontal cortex control. This is the part of the brain that controls motivation and reward structures. This is the part of the brain where sexual desire manifests. It is to re-balance neurotransmitters influencing sexual desire and increase dopamine and norepinephrine. These are both responsible for sexual excitement. Sprout Pharmaceuticals will continue to seek FDA approval for ADDYI as there currently is no medicine on the market to help women with this disorder.