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FDA endorsed Phase 2 study design and openness to single pivotal Phase 3 trial for Lybrido, de-risking regulatory path.
Arletta Pharma Solutions announced that the US Food and Drug Administration has endorsed core elements of its proposed Phase 2 MONARCH study for Lybrido, an investigational therapy for Female Sexual Interest/Arousal Disorder and Hypoactive Sexual Desire Disorder, and expressed openness to a single pivotal Phase 3 study supporting a future New Drug Application. The FDA confirmed that the proposed doses and treatment duration appear reasonable and that a single primary endpoint focused on sexual desire is acceptable. The Agency also indicated openness to relying on one pivotal Phase 3 trial combined with confirmatory evidence from the broader development program. The FDA requested refinements in study design, statistical approach, and safety characterization, which Arletta considers constructive and consistent with expectations. The response follows a Type C meeting package and provides a clear framework for advancing Lybrido through Phase 2 and toward pivotal development in the United States.
FDA endorsed Phase 2 study design and openness to single pivotal Phase 3 trial for Lybrido, de-risking regulatory path.