A drug developed to improve the sexual desire of premenopausal women has met the main goal of two late stage clinical trials, its developer Palatin Technologies Inc. revealed on Tuesday, Nov. 1
The experimental drug called bremelanotide, which is aimed at women who are distressed by lack of libido was compared with placebo in 24-week studies that involved over 1,200 women.
Results showed the drug was linked with significant improvements on scales that measure levels of desires and distress. Participants of the study were women suffering from hypoactive sexual desire disorder (HSDD).
Also known as inhibited sexual desire, HSDD is the most common form of female sexual dysfunction. It is marked by lack or absence of sexual fantasies and desire for sexual activity to the extent it causes marked distress or interpersonal difficulties.
Study investigator Sheryl Kingsberg, from Case Western Reserve University School of Medicine in Ohio, said that the distress component of the condition reflects the profound negative impact of HSDD that can influence a woman's self image, relationships and even her quality of life outside of the bedroom.
In phase 3 trials, significant reduction in distress was observed in women who used bremelanotide.
"In Phase 3 trials bremelanotide was used as needed by premenopausal women with HSDD, with a single dose self-administered in anticipation of sexual activity," said Palatin Chief Medical Officer Johna Lucas.
"The Phase 3 studies demonstrated that bremelanotide provided a meaningful benefit for those patients who responded to the drug candidate. We look forward to the opportunity to provide a new and differentiated treatment option to the many women suffering from HSDD."
The most common side effect of the drug was nausea albeit it was generally mild and the drug was well tolerated and had no newly identified safety issues.
Palatin's drug is comparable to a female Viagra. It is to be taken as needed before a sexual activity instead of being taken every day. The drug, however, is not a pill. It needs to be subcutaneously administered using an autoinjector.
Palatin is expected to seek U.S. approval from regulators for use of bremelanotide in the second half of 2017.
If the drug gets approved, it will compete with the controversial Addyi, a drug that women need to take daily for their low libido problems. The drug hit the market despite concerns over its side effects such as fainting when it is taken with alcohol and other medicines.