By Rebecca Bowers, Contraceptive Technology Update Writer
The Food and Drug Administration has approved Addyi (flibanserin, Sprout Pharmaceuticals, Raleigh, NC) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women.
The drug is the first such treatment to be approved by the FDA for this condition. Addyi is projected to be available in October 2015.
Hypoactive sexual desire disorder is characterized by low sexual desire that causes marked distress or interpersonal difficulty. The condition is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. According to the International Society for Sexual Medicine, the condition is thought to affect one in every 10 women.
Addyi can cause hypotension and syncope. Such risks are increased and more severe when patients drink alcohol or take Addyi with CYP3A4 inhibitors that interfere with the breakdown of the drug in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Healthcare professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing the drug.
The approval comes with this risk evaluation and mitigation strategy:
· Clinicians must be trained and certified to prescribe Addyi.
· Providers must counsel patients and make sure they are aware of the increased risk for hypotension and syncope associated with use of the drug. Patients also must warned about the risks of using alcohol while taking Addyi.
· Dispensing pharmacies must undergo a training and certification process to dispense the drug.
· Pharmacies may fill only prescriptions written by certified doctors.
· Before dispensing Addyi, pharmacists must counsel patients not to drink alcohol while taking the drug.
In addition, the FDA is requiring Sprout Pharmaceuticals to conduct three studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.
Look for a full roundup of details around this historic drug in Contraceptive Technology Update.