Amag Pharmaceuticals announces publication of Phase 3 Vyleesi data
AMAG Pharmaceuticals announced that the data from its two pivotal, double-blind placebo-controlled Phase 3 trials and its voluntary open-label one year extension studies were published in Obstetrics & Gynecology. These publications are currently available online and will appear in the November print issue. In both randomized placebo-controlled clinical trials, Vyleesi met the pre-specified co-primary efficacy endpoints of improvement in desire and reduction in associated distress as measured by validated patient-reported outcome instruments. These endpoints are the hallmark symptoms of hypoactive sexual desire disorder. The RECONNECT data from approximately 1,200 women was the basis for the June 2019 U.S. Food and Drug Administration approval of Vyleesi, the first and only as-needed treatment for premenopausal women with acquired, generalized HSDD. While patients were still blinded to their treatment assignment, they were asked via a validated, questionnaire, "Compared to the start of the study to what degree do you think you have benefited from treatment?" Nearly 60 percent of patients taking Vyleesi reported feeling "better" to "very much better" compared to 36 percent of patients in the placebo group. Among those who completed the placebo-controlled, double blind portion of the study, approximately 80 percent of those women chose to continue to the voluntary open-label extension phase where all patients received study drug. Data from this 52-week open-label extension showed sustained efficacy for patients who had received study drug in the initial study and no new safety signals were observed. Additionally, patients who began taking study drug during the extension phase for the first time showed similar improvements in desire and reductions in associated distress to those seen during the randomized portion of the study in patients treated with study drug. In the pivotal trials, the most common adverse events were nausea, flushing, injection site reactions, headache and vomiting. The majority of events were reported to be transient and mild-to-moderate in intensity. In the clinical trials, Vyleesi caused small, transient increases in blood pressure, and is contraindicated in women with uncontrolled high blood pressure or known cardiovascular disease.