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Daily Research Brief

PT-141 -: Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.

Drug and therapeutics bulletin · 2021

3 minute read1/1/2021human

The US Food and Drug Administration (FDA) has approved two drugs for 'hypoactive sexual desire disorder' in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none.

What the study reported

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Confirm the complete study design, intervention identity, population or model, outcomes, statistical context, and limitations in the linked source before approval.

Research context only. This brief summarizes a published source and does not establish clinical efficacy, safety, dosing, or suitability for human or veterinary use. Review the original paper before drawing conclusions.
Read the original source · Drug and therapeutics bulletin
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