Female Testosterone Patch Data Are Under Review

Pharmacy Times, Volume 0, 0

The FDA has granted priorityreview to Intrinsa(testosterone transdermalsystem). It is an investigationalfemale testosterone patchfor the treatment of hypoactivesexual desire disorder(HSDD) in surgically menopausalwomen. If approved,Intrinsa (Procter & GamblePharmaceuticals) would bethe first prescription treatmentfor HSDD.

HSDD is defined as a lackof sexual desire that causesa woman personal distressand is one of the most commonfemale sexual healthproblems. The data sent tothe FDA were based on findingsfrom 2 phase 3 clinicaltrials presented recently atthe 52nd Annual ClinicalMeeting of the AmericanCollege of Obstetricians andGynecologists and the 86thAnnual Meeting of the EndocrineSociety. The 2 24-week, randomized, double-blind,placebo-controlled,multicenter studies included1000 surgically menopausalwomen with HSDD. The participantsranged from 20 to70 years of age and werereceiving either oral or transdermalestrogen therapy.The study tested the efficacyand safety of the femaletestosterone patch.