PT-141
Also: bremelanotide, Vyleesi
4 papers: 3 human studies, 1 review or preprint.
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Summary
PT-141, or bremelanotide, is a synthetic peptide that activates melanocortin receptors, developed out of research on analogues of alpha-melanocyte-stimulating hormone. It is an approved medicine in the United States, sold as Vyleesi, for one specific indication in women. Its earlier development as a nasal spray for erectile dysfunction in men was not the route that reached approval.
What it targets
Bremelanotide acts on melanocortin receptors rather than on blood flow directly. Two identical phase 3 trials in 1,267 premenopausal women with hypoactive sexual desire disorder found that, over 24 weeks, sexual desire scores rose and distress about low desire fell significantly more than on placebo, though the absolute change on each scale was small, around a third of a point. An earlier phase 2b trial in 327 women found about half an additional satisfying sexual event per month over placebo. In men, a 342-person trial of an intranasal formulation in erectile dysfunction that had not responded to sildenafil reported a positive clinical result in about a third of the treated group against under a tenth on placebo. A pooled safety review across the development programme reported nausea in 40 percent of participants, flushing in 20 percent and headache in 11 percent, with focal skin hyperpigmentation in more than a third of participants who took up to 16 consecutive daily doses, and small transient increases in blood pressure.
Clinical Research
Suppliers stocking PT-141
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