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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/vyleesi-phase-3-data-to-be-presented-at-the-13th-european-society-of-gynecology-congress-300939331.html
SOURCE Palatin Technologies, Inc.