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But what happens when those signals aren't strong enough

N Engl J Med 1992;326:13161322

They are typically utilized when an FDA-approved drug is unavailable or when the approved version is unsuitable due to specific medical requirements, such as an allergy or the necessity of a different dosage form or formulation.

This dose was selected based on Phase 3 data from the RECONNECT trials, which randomized 1,247 premenopausal women with HSDD to bremelanotide 1.75 mg or placebo over 24 weeks [1]