Palatin Initiates Clinical Program For Bremelanotide Co-Formulated With PDE5i For ED Treatment

(RTTNews) - Palatin Technologies Inc. (PTN) said Thursday that it has initiated a clinical development program evaluating bremelanotide, a melanocortin receptor 4 (MCR4) agonist, co-formulated with a PDE5 inhibitor or PDE5i, for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.

The company noted that published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i.

Palatin said it has developed a co-formulation of bremelanotide and a PDE5i which can be administered as a single injection. The initial trial for the clinical development program for this novel co-formulation will be a Phase 2 clinical study of bremelanotide co-administered with a PDE5i in erectile dysfunction patients who have not responded to PDE5i treatment.

The study is currently expected to start in the fourth quarter of the calendar year 2023.

Bremelanotide (1.75mg) is the active agent in Vyleesi, approved by the U.S. Food and Drug Administration for the treatment of premenopausal women with hypoactive sexual desire disorder.

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