Vyleesi™ Phase 3 Data To Be Presented At The 13th European Society Of Gynecology Congress
CRANBURY, N.J., Oct. 16, 2019
CRANBURY, N.J., Oct. 16, 2019 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) announced today that data from two pivotal, double-blind placebo-controlled Phase 3 trials (RECONNECT) and the Exit Survey/Interview data on Vyleesi™ (bremelanotide injection) for hypoactive sexual desire disorder (HSDD) will be presented at the 13th European Society of Gynecology Conference in Vienna, Austria. The conference and the data presentations are jointly sponsored by Palatin and Palatin's North American licensee for Vyleesi, AMAG Pharmaceuticals, Inc.
Both randomized, placebo-controlled clinical trials of Vyleesi met the pre-specified co-primary efficacy endpoints of improvement in desire, and reduction in associated distress, as measured by validated patient-reported outcome instruments. These endpoints are the hallmark symptoms of HSDD. The RECONNECT study, consisting of data collected from approximately 1,200 women, served as the basis for the June 2019 U.S. Food and Drug Administration approval of Vyleesi. Vyleesi is the first and only as-needed treatment for premenopausal women with acquired, generalized HSDD.
On Wednesday, October 16th, Sheryl Kingsberg, Ph.D., Division Chief of Behavioral Medicine, University Hospitals Cleveland Medical Center, will present her keynote presentation "Bremelanotide (BMT) for Hypoactive Sexual Desire Disorder (HSDD): Efficacy Analyses from the RECONNECT Studies," during the Opening Lecture session "Hypoactive Sexual Desire Disorder: Addressing an Unmet Medical Need."
"As a clinician who treats women with HSDD, I am pleased that Vyleesi is now available as a safe and effective treatment option for women in the U.S.," said Dr. Kingsberg. "It is my hope that my European colleagues will soon have the ability to prescribe Vyleesi to their patients."
A poster will be presented entitled "Bremelanotide Provides Meaningful Treatment Benefits for Premenopausal Women With Hypoactive Sexual Desire Disorder," outlining data from the exit survey and interview results from women completing the Phase 3 studies. The poster can be found on the Palatin website at https://www.palatin.com/resources/bremelanotide-fsd-posters/.
In addition, on Friday, October 18th, as part of the session entitled "Sexuality; Fertility and ART Sexual and Reproductive Health Care – A Forgotten Part of Obstetrics and Gynecology," Rosella Nappi will present "Treating Hypoactive Sexual Desire Disorder: Addressing an Unmet Medical Need," featuring RECONNECT Phase 3 study data.
"The ESG conference is a fantastic forum to present the robust Vyleesi data to clinicians and Key Opinion Leaders in female sexual health in Europe," stated Carl Spana, Ph.D., President and CEO of Palatin. "We strive to bring awareness of Vyleesi as a safe and effective treatment option for premenopausal women suffering from HSDD to clinicians globally."
About Vyleesi™ (bremelanotide injection)
Vyleesi is approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The prefilled Vyleesi autoinjector is self-administered into a woman's abdomen or thigh at least 45 minutes before anticipated sexual activity and can be taken at any time of day. Women should not inject more than one dose of Vyleesi within 24 hours of their last dose and should not inject more than eight doses of Vyleesi within a month. While the exact mechanism of action is unknown, Vyleesi is believed to bind to, and exert its effects via, melanocortin receptor agonism in the central nervous system.
The most common side effects of Vyleesi include nausea, flushing, injection site reactions and headache. Do not use Vyleesi if you are pregnant, or have uncontrolled hypertension, known heart disease or are taking oral naltrexone-containing products intended to treat opioid or alcohol addiction. Although less common, Vyleesi may also cause vomiting or darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast. Women who can become pregnant should use effective birth control during treatment with Vyleesi.
For additional product information, including full prescribing information, please visit www.vyleesi.com.
The VYLEESI trademark is owned by AMAG Pharmaceuticals, Inc. in the United States, Canada and Mexico, and by Palatin Technologies, Inc. in the European Union and other countries throughout the world.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is focused on developing drugs that modulate the melanocortin system to treat diseases and conditions with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com.
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SOURCE Palatin Technologies, Inc.