The U.S. Food and Drug Administration has approved Addyi (flibanserin) to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).
“The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
According to FDA, HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
The Agency also said HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation, or the sexual partner.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
The FDA explained that Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.
The government agency further explained that because of the alcohol interaction the use of alcohol is contraindicated while taking Addyi.
Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi, the agency warned.
Furthermore, the agency said certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber, and pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.
Do you want to add feedback to this story? Please add comment in box below.
Like our Facebook page https://www.facebook.com/TheReadersBureau
Follow us on Twitter https://twitter.com/readersbureau21