A Federal Drug Administration subcommittee has approved the use of a drug to help relieve the problem of hypoactive sexual disorder in women. The drug called ADDYI was developed to restore sexual desire in women who have not yet reached menopause. Known within the medical community as HSDD, it is the most commonly reported form of sexual dysfunction in women and has been for the last 40 years. According to the drug’s manufacturer Sprout Pharmaceuticals, HSDD affects roughly one in three women, with one in ten reporting that their desire for sexual intimacy is very distressing. Once final approval is granted by the FDA, ADDYI will be the only drug on the market to address this disorder.
ADDYI is a non-hormonal drug that was tested in over 11,000 women making it one of the most studied and well-researched drugs coming to market. It acts on the patient by elevating the neurotransmitters dopamine and norepinephrine while reducing the levels of serotonin in the pre-frontal cortex of the brain. Dopamine and norepinephrine both act to enhance sexual desire and pleasure while serotonin acts to depress it. Studies showed that side effects of the drug were generally minor consisting mostly of nausea, dizziness and sleepiness.
The studies were conducted in double-blind tests over a 24-week period. In a double-blind study, neither the patient nor the administering physician knows whether the patient is receiving the actual drug or a placebo. Test subjects were screened and were selected to be in long term relationships for 10 years, and had HSDD for half of that time on average (4-5 years). Self-reporting from the patients showed that some experienced increased sexual desire in as early as four weeks, and by six months up to 60% reported improvement.
While the full FDA has not acted on the drug’s application, the recommendation by the sub-committee is a positive sign for ultimate approval. If it is approved it will be the first drug on the market that achieves the goals of enhancing women’s sexual response, the frequency for the desire of sex, and reducing the distress for the loss of sexual events.
Sprout Pharmaceuticals is a Raleigh, North Carolina based company whose goal is to provide a drug to treat HSDD. It was founded as a spin-off from Slate Pharmaceuticals in 2011.