In a shot of bad news to sex lovers, the US FDA gave an initial "sorry, dear" to the regulatory approval of bremelanotide for erectile dysfunction. Bremelanotide acts on the melanocortin receptors of the brain. Previous research showed that bremelanotide can increase sexual arousal and might be of use for treating various types of sexual dysfunction. There is particular hopes that this chemical might be the female equivalent of viagra. The FDA said it was particularly concerned with the possibility that bremelanotide might raise blood pressure in some men. It isn't clear if this will affect the approval process for women, which is on a separate track.

The FDA also expressed concerns that the data showing that the chemical (also called PT-141) was clearly effective in treating erectile dysfunction. The door seems open on applying for permission to use PT-141 as a second-string treatment, perhaps in combination with other ED drugs.

This drug is in the middle of the regulatory process for getting approval to treat female sexual arousal disorder; no word yet if the trials on men will affect the approval process for women. No drug is currently approved for treating female sexual arousal disorder.

Investors rushed to sell-off stock in Palatin Industries, the company that owns the rights to bremelanotide. Sales volume spiked to 70 times normal, and the price dropped over 60 percent (it has since stabilized, but could change dramatically with any additional news).

Links

• Aphrodisiology article on PT-141
• Bioworld Report
• Palatin Press Release announcing delay of phase III trials for using PT-141 for erectile dysfunction.