The FDA has approved flibanserin (Addyi – Sprout) for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not caused by another medical or psychiatric condition, the effects of another drug, or relationship difficulties. Flibanserin is the first drug to be approved for treatment of HSDD. It is not approved for use in men or postmenopausal women. Previous FDA reviews of flibanserin in 2010 and 2013 did not result in approval.
THE DISORDER — HSDD is defined as a deficiency or lack of sexual thoughts or desire that causes personal distress or interpersonal difficulty. It is characterized as lifelong or acquired, and as situational (related to a specific partner, situation, or type of stimulation) or generalized. Estimates of the prevalence of HSDD in women vary widely; one study found that 14% of premenopausal women 20-49 years old have HSDD.1
The FDA has approved naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.
STANDARD TREATMENT — Laxatives and stool softeners are commonly used, often in combination, for initial treatment of opioid-induced constipation, but their efficacy is limited. Methylnaltrexone (Relistor), a subcutaneously injected opioid antagonist, and ...