Bremelanotide is a research compound that we have written about many times in the past. Research has been carried out for some time on its use in the treatment of sexual dysfunction and the latest studies were discontinued in 2008 due to vastly increased blood pressure levels amongst those taking the drug. However, Palatin Technologies (the pharmaceutical company behind bremelanotide) has just boasted positive Phase 1 results. They say that they have eliminated the problem of the increase in the level of blood pressure by having the bremelanotide administered subcutaneously. This method of application presents consistent blood plasma levels without changing the blood pressure levels. Not only may these results get bremelanotide further down the regulatory route to a license, but Erectile Dysfunction is not the only condition that is treatable in this way. As of yet there is no FDA approved treatment for Female Sexual Dysfunction(with Intrinsa only licensed in the EU), but Palatin thinks it may have a chance with bremelanotide.
Palatin will meet with the Food and Drug Administration (FDA) towards the end of 2010 to discuss the next phase of bremelanotide’s trials. In this phase, Palatin hope to test bremelanotide as a treatment on its own and also as a drug which will work alongside a PDE-5 inhibitor (such as Viagra, Cialis or Levitra). The PDE-5 inhibitor family of medications is not successful for all men who suffer from erectile dysfunction, so combining both or even a new mono-therapy may make for some promising results.
Over 25% of men with ED do not respond to oral treatments currently available, such as Viagra. The CEO of Palatin explains that this is another reason why the future of bremelanotide is important for the likes of these men who don’t have another option. As it stands, what will not come with this treatment is the convenience of administering it orally. Subcutaneous application might inhibit the popularity of the treatment but if it means that men who otherwise have no other option may finally be able to treat their condition, perhaps convenience will not be the primary concern.