Tuesday, January 31, 2017

Palatin Technologies, Inc. (PTN) Takes Bremelanotide to Phase 3 Clinical Trials for Hypoactive Sexual Desire Disorder (HSDD)

Hypoactive Sexual Desire Disorder, or HSDD, is a common female sexual dysfunction where the woman feels a decrease in sexual desire and an increase in personal distress from this lack of desire. It’s a disorder affecting approximately one in 10 women, and it often leads to relationship issues. According to ‘Hypoactive Sexual Desire Disorder: A Review of Epidemiology, Biopsychology, Diagnosis, and Treatment’ (http://dtn.fm/H565a), HSDD is present in just under 9% of women aged 18 to 44, over 12% of women aged 45 to 64, and over 7% of women aged over 65.

The report continues to explain that more than half of women suffering from HSDD do not seek help from their doctors or physicians. This has been largely attributed to fear and embarrassment. Despite there being a tool called ‘The Decreased Sexual Desire Screener’, available in general practices, HSDD still remains underdetected and undertreated. However, there are also new drugs being developed for the treatment of HSDD.

In 2015, a drug called Addyi (flibanserin) was approved by the Federal Drug Administration (FDA) as the first centrally acting daily medication for HSDD. Recently, Palatin Technologies, Inc. (NYSE MKT: PTN) announced Phase 3 development of Bremelanotide. Based on the biopharmaceutical company’s findings, Bremelanotide is thought to have several distinct advantages over Addyi.

Bremelanotide has a different form of administration than Addyi. Bremelanotide can be taken as needed with an onset of efficacy in approximately 30 minutes, effective for a period of eight to 10 hours. In addition to this, the drug is not expected to have a boxed warning, unlike Addyi, which has the potential of causing hypertension and syncope in certain settings.

Bremelanotide is also not believed to interact with alcohol, or have any contraindications. On the other hand, patients taking Addyi are advised to abstain from alcohol and the drug is not to be used with strong CYP3A4 or in patients with hepatic impairments, as this could increase the risk of hypertension and syncope.

The Phase 2B clinical trials involved 327 female patients, some taking Bremelanotide and others a placebo, at home, for a 20-week period. All patients suffered from some form of female sexual dysfunction. The results showed a 50% increase in Satisfying Sexual Events (SSEs) with Bremelanotide, compared to a 12% increase with placebo. Other factors that improved included an improvement in overall sexual function and a decrease in personal distress from the sexual dysfunction.

Currently, PTN’s Bremelanotide is in Phase 3 development as a treatment for hypoactive sexual desire disorder in premenopausal women. The pivotal Phase 3 clinical trials were initiated in December 2014 and January 2015, respectively, with the efficacy portion completed back in August 2016. The topline data for the drug is expected to be available in the fourth quarter of 2016. If the data is positive, the data will support an NDA filing in 2H2017 and potential NDA approval in 2H2018.

For more information, visit www.Palatin.com

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