Addyi Continues in FDA Approval Process Despite Setbacks
An 18 to 6 vote by the U.S. Food and Drug Administration (FDA), Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee decided that if specific risk management steps are taken, the benefits of Sprout Pharmaceuticals’ formerly rejected drug Addyi (flibanserin) outweigh the risks in treating perimenopausal Hypoactive Sexual Desire Disorder (HSDD).
What is Hypoactive Sexual Desire Disorder (HSDD)?
Female Hypoactive Sexual Desire Disorder occurs when deficiency or lack of sexual drive and desire creates notable personal and/or interpersonal distress. Many factors impact adult female sexual function, including hormonal changes such as perimenopausal and postmenopausal states.
Sexual dysfunction is strongly associated with feelings of low self esteem and unhappiness, thus limits optimal quality of life. Approximately 1 of 10 United States women suffer from distress due to sexual dysfunction.
Treatment for HSDD includes lifestyle changes, medication adjustments, hormonal and relational therapy. Although no pharmaceutical treatment is available for female HSDD, the drug Addyi is currently under review for FDA approval for treatment of perimenopausal hypoactive sexual desire disorder.
What is Addyi?
Addyi is an innovative, non-hormonal prospective drug that targets treatment of HSDD in premenopausal females. Classified as a Multifunctional Serotonin Agonist Antagonist (MSAA), Addyi balances prefrontal cortex control by replenishing dopamine and norepinephrine and limiting serotonin to increase sexual desire and remove sexual inhibition, respectively.
After extensive clinical trials (over 11,000 women evaluated), research has shown Addyi’s ability to reduce distress from sexual dysfunction and increase sexual desire and satisfaction in premenopausal women. If approved by the FDA, Addyi will be the first treatment available to women suffering from HSDD. However, Addyi has been criticized for its side effects of dizziness, nausea and sleepiness, and the FDA has yet to fully approve the drug.