Palatin Technologies, the New Jersey company developing the drug, reformulated it into a subcutaneous injection, which did not affect blood pressure in new safety studies. On that basis, Palatin went ahead with a phase IIB trial in 327 premenopausal women with FSAD, HSDD, or both. The company announced positive results last month.
According to a statement, "[the results] demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of satisfying sexual events and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo."
There were no blood pressure problems, although some women did quit the drug because of nausea and vomiting of mild to moderate intensity. Palatin intends to launch a phase III trial next year.
Dr. Krychman has disclosed that he is a consultant/advisor for Warner Chilcott, Pfizer, and Sprout.