Peer-reviewed paper presents notable mechanism
of action findings
Bremelanotide significantly increased sexual
desire for up to 24 hours post administration
CRANBURY, NJ, Oct. 17,
2022 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE
American: PTN), a biopharmaceutical company developing
first-in-class medicines based on molecules that modulate the
activity of the melanocortin receptor system, today announced the
publication of a third-party clinical study with bremelanotide
(Vyleesi) in the Journal of Clinical Investigation entitled
"Melanocortin 4 receptor agonism enhances sexual brain processing
in women with hypoactive sexual desire disorder," by Thurston, et
al. (Reference: J Clin Invest. 2022;132(19):e152341.
https://doi.org/10.1172/JCI152341). Vyleesi is the first and
only as-needed treatment approved by the U.S. Food and Drug
Administration (FDA) for premenopausal women with HSDD.
The important findings in the double-blinded, placebo
controlled, crossover study showed that bremelanotide enhanced
sexual brain processing, including a significant increase in sexual
desire for up to 24 hours after administration compared with
placebo (statistically significant P ≤ 0.01). Increased
satiety (appetite fullness feeling) and decreased food intake with
bremelanotide treatment was also noted. Although other studies have
been conducted showing the difference in sexual brain function
between women with HSDD and non-HSDD women, this is the first trial
to study the effects of melanocortin 4 receptor agonism with
bremelanotide on sexual brain processing in women with HSDD.
"This extremely well-done clinical trial helps define Vyleesi's
positive effects on sexual brain function and the relationship to
increases in sexual desire in women with HSDD," stated Carl Spana, Ph.D., President and CEO of Palatin.
"The study correlates imaging data with increased sexual desire for
up to 24 hours post Vyleesi administration as reported by the
participants. We are extremely excited and appreciative for this
important data which demonstrates the beneficial impact of HSDD on
the sexual brain and helps explain Vyleesi's mechanism of action in
increasing sexual desire in women with HSDD."
The trial registration can be found at ClinicalTrials.gov under
NCT04179734. This was an investigator-sponsored study funded by
AMAG Pharmaceuticals Inc. (previous Vyleesi collaboration partner)
and the Medical Research Council and National Institute for Health
Research of the United
Kingdom.
About Vyleesi® (bremelanotide injection) for Hypoactive
Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the
FDA for premenopausal women with acquired, generalized HSDD.
Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside
the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun
Pharma in China and Kwangdong
Pharmaceuticals in South Korea.
Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com and www.vyleesipro.com.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class
medicines based on molecules that modulate the activity of the
melanocortin receptor systems, with targeted, receptor-specific
product candidates for the treatment of diseases with significant
unmet medical need and commercial potential. Palatin's strategy is
to develop products and then form marketing collaborations with
industry leaders to maximize their commercial potential. For
additional information regarding Palatin, please visit Palatin's
website at www.Palatin.com and follow Palatin on Twitter at
@PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin, such as
statements about Vyleesi results and potential market, are
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. Palatin intends that such
forward-looking statements be subject to the safe harbors created
thereby. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that could cause Palatin's
actual results to be materially different from its historical
results or from any results expressed or implied by such
forward-looking statements. Palatin's actual results may differ
materially from those discussed in the forward-looking statements
for reasons including, but not limited to, results of clinical
trials, regulatory actions by the FDA and other regulatory and the
need for regulatory approvals, Palatin's ability to fund
development of its technology and establish and successfully
complete clinical trials, the length of time and cost required to
complete clinical trials and submit applications for regulatory
approvals, products developed by competing pharmaceutical,
biopharmaceutical and biotechnology companies, commercial
acceptance of Palatin's products, and other factors discussed in
Palatin's periodic filings with the Securities and Exchange
Commission. Palatin is not responsible for updating for events that
occur after the date of this press release.
Palatin Technologies® and Vyleesi® are registered trademarks of
Palatin Technologies, Inc.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/palatin-announces-publication-of-vyleesi-bremelanotide-fmri-study-in-women-with-hypoactive-sexual-desire-disorder-hsdd-301650502.html
SOURCE Palatin Technologies, Inc.