What is Bremelanotide?
We are developing bremelanotide as a treatment for female sexual dysfunction, or FSD. Bremelanotide is currently in Phase 3 clinical trials for a type of FSD with decreased sexual desire that is also known as hypoactive sexual desire disorder, or HSDD. The Phase 3 trials are designed to confirm the effectiveness of bremelanotide for treating HSDD in premenopausal women, monitor side effects and collect information that will allow bremelanotide to be used safely.
Bremelanotide is a melanocortin agonist, a synthetic peptide analog of a naturally occurring hormone called alpha-MSH. The mechanism of action involves helping to activate internal pathways involved in the body’s normal sexual responses.
How is Bremelanotide Used?
Bremelanotide is given by subcutaneous injection using an autoinjector. There is no visible needle with the autoinjector. In Phase 3 clinical trials women administer bremelanotide by pressing the autoinjector against their thigh or abdomen – the autoinjector does the rest.
Bremelanotide is used only with anticipated sexual activity. It is an on-demand drug, taken only when there is a need for the drug.
What are Clinical Trial Results with Bremelanotide?
We have completed a Phase 2B clinical trial in which 394 patients were dosed. Results from this trial supported starting Phase 3 trials.
We completed enrollment in our Phase 3 clinical trial in the 4th quarter of calendar 2015. Each patient is in the trial for up to eight months, and we anticipate that we will have database lock (completion of the patient studies) in the 3rd quarter of calendar 2016, followed by topline (preliminary) results. Following database lock, clinical trial data will be analyzed and, assuming that we believe the data would support approval of bremelanotide for HSSD, a New Drug Application will be submitted to Food and Drug Administration.