PT-141 (nasal)
Status
No approved product. No FDA-approved labeling exists for intranasal bremelanotide; no FDA approval of a nasal formulation was found. The subcutaneous product Vyleesi is approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women, and is contraindicated in uncontrolled hypertension and known cardiovascular disease.
What it is
A nasal spray form of the melanocortin agonist bremelanotide.
What published research measured
Bremelanotide delivered intranasally. The molecule itself has a completed randomized programme — the RECONNECT trials supported approval of the subcutaneous formulation for hypoactive sexual desire disorder in premenopausal women, with statistically significant but modest effects on desire and distress scores. The intranasal route is a separate matter and its history is the informative part: nasal bremelanotide was developed first and that development was discontinued after dose-related increases in blood pressure were observed, which is precisely why the approved product is subcutaneous. Anyone using a nasal formulation is using the route the sponsor abandoned on cardiovascular grounds. Nausea is the most common adverse effect, and transient blood pressure elevation with compensatory heart rate reduction is documented.
Source
RECONNECT phase 3 trials of subcutaneous bremelanotide · Discontinuation of the intranasal formulation over blood pressure elevation · FDA labeling for Vyleesi
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.