Bremelanotide for Sexual Dysfunction

Palatin Technologies is developing bremelanotide as a subcutaneous product intended for both erectile dysfunction (ED) and female sexual dysfunction (FSD).  The primary indication for ED will be in patients non-responsive to currently approved therapeutics.

Palatin Technologies has extensive clinical experience with bremelanotide, an MC4-R peptide agonist.  Over 2,000 patients have received bremelanotide, with demonstrated efficacy for both ED and FSD.

Studies have demonstrated efficacy in a broad range of patients, including patients non-responsive to treatment with phosphodiesterase-5 (PDE-5) inhibitors such as sildenafil (Viagra®).  Co-administration of bremelanotide with sildenafil demonstrated a synergistic effect, with enhanced response compared to only sildenafil.

Prior studies with bremelanotide focused on intranasal delivery, with a small number of patients experiencing an increase in blood pressure.  Following discussions with the Food and Drug Administration (FDA), Palatin discontinued work on bremelanotide as an intranasal first-line therapy for sexual dysfunction.  Palatin expects to submit additional data surrounding blood pressure effects to the FDA by mid-2009 with a plan to move forward as a treatment in patients non-responsive to current therapies.

For more information on Bremelanotide for Sexual Dysfunction, download the fact sheet.