Flibanserin for hypoactive sexual desire disorder (HSDD)

03 Sep 2015
03 Sep 2015

The first drug for the treatment of acquired low sexual desire (in premenopausal women) was recently approved by the FDA. It is registered specifically only for low sexual desire which causes distress or interpersonal difficulty and is not due to another medical or psychiatric condition, relationship difficulties, or the effects of other drugs or substance abuse.

Acquired HSSD means that it develops in a patient who had no previous issues with sexual desire.

Flibanserin will only be available through certified health care professionals and pharmacies, due to the significant risks of severe hypotension and syncope, especially if taken with alcohol or moderate/strong CYP3A4 inhibitors. Known as ADDYI® in the USA (it is not registered in South Africa yet), it comes with these black-boxed warnings:

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS

Contraindicated with Alcohol The use of ADDYI and alcohol increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1)]. Therefore, alcohol use is contraindicated in patients taking ADDYI [see Contraindications (4)]. Before prescribing ADDYI, assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed ADDYI about the importance of abstaining from alcohol use. Because of the increased risk of hypotension and syncope due to an interaction with alcohol, ADDYI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program [see Warnings and Precautions (5.2)].

Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.3)]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4)].

Contraindicated in Patients with Hepatic Impairment The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.6)]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4)].

Clinical trials of flibanserin reported, on average, an increase of 0.5 to 1 additional satisfying sexual event per month.

Proponents have welcomed the introduction of the first drug for sexual desire disorders whilst opponents have pointed out that the drug carries significant risks for only minimal benefits. We’ll watch this relatively controversial drug approval with interest.