US drug agency approves drug for low sexual desire in womenBMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4522 (Published 20 August 2015) Cite this as: BMJ 2015;351:h4522
The US Food and Drug Administration (FDA) has approved the first drug for the treatment of women with low sexual desire. The drug, flibanserin, which is made by Sprout Pharmaceuticals, of Raleigh, North Carolina, will be marketed under the name Addyi.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research in a statement announcing the drug’s approval.
The approval comes after the agency was subject to an intense lobbying campaign by advocates who accused the FDA of gender bias, saying that it had failed to approve drugs for sexual disorders in women while approving a number of drugs, such as erectile dysfunction drugs, to enhance sexual experiences in men. Opponents of flibanserin’s approval, however, said that its side effects and risks far outweighed its benefits.
Under the FDA approval the drug will be indicated for premenopausal women with “acquired, generalized hypoactive sexual desire disorder [HSDD],” a condition characterized by low sexual desire that causes marked distress or interpersonal difficulty that is not due to a coexisting medical or psychiatric condition or problems in the woman’s relationship.
Flibanserin contains a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but how it affects a woman’s sexual desire is not known. In clinical trials submitted to the FDA for approval, premenopausal women reported the number of satisfying sexual events, their level of sexual desire over the preceding four weeks scored on a range of 1.2 to 6.0, and any reported distress related to low sexual desire on a scale on a range of 0 to 4.1
On average, a daily dose of 100 mg of flibanserin at bedtime was associated with an increase in the number of satisfying sexual events by 0.5-1.0 additional event a month over placebo, an increase in sexual desire scores by 0.3-0.4 over placebo, and a decrease in distress scores related to sexual desire by 0.3-0.4 over placebo.
Flibanserin can cause severe hypotension and syncope, especially when used with alcohol. As a result, alcohol is contraindicated while taking the drug. Other side effects include dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.
Because of the drug’s side effects and contraindications, flibanserin has been approved with a risk evaluation and mitigation strategy, which will require healthcare providers to complete a training program before prescribing the drug and to counsel patients using a Patient-Provider Agreement form, including information about the risk of hypotension and syncope and the importance of not drinking alcohol during treatment.
Woodcock said, “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
Cite this as: BMJ 2015;351:h4522