Physicians can now complete the training and paperwork required to prescribe flibanserin ( Addyi, Sprout Pharmaceuticals ), a new centrally acting, nonhormonal daily medication that treats female hypoactive sexual desire disorder.
The Food and Drug Administration’s August 2015 approval of flibanserin came with a required REMS (Risk Evaluation and Mitigation Strategy ) to address safety concerns.
Flibanserin, which the FDA had twice previously declined to approve, has an increased risk for syncope and hypotension with alcohol and moderate or strong CYP3A4 inhibitors, such as proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, and antifungals. Flibanserin taken alone also caused hypotension and syncope in a few patients during clinical trials.
The REMS addresses these risks by requiring all prescribers to complete training and a knowledge assessment about flibanserin’s risks and to enroll in a REMS certification program for the drug. Prescribers must also review a patient-provider agreement form with patients and have both parties sign before prescribing flibanserin.
Outpatient pharmacies must designate a representative to complete training and knowledge assessment, train their staff, and counsel every patient receiving flibanserin to abstain from alcohol. Inpatient pharmacies have similar training requirements and may not dispense flibanserin for outpatient use.
Flibanserin is approved for treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women only. It is a medication that is meant to be taken on a chronic basis, acting as a mixed agonist/antagonist for dopamine and serotonin receptors. In clinical trials, it showed a statistically significant, but modest improvement in reported sexual desire and the number of sexually satisfying events per month.
The certification materials are available online at www.Addyi.com . To complete the certification process, prescribers and pharmacists should fax the completed knowledge assessment and enrollment forms to 844-694-3373 or email scanned copies to AddyiREMSEnroll@AddyiREMS.com .
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