CRANBURY, N.J., Feb. 26, 2016 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, announced that data on a bremelanotide and
alcohol use interaction Phase 1 study were presented today in a
Research Podium Session at the International Society for the Study
of Women's Sexual Health (ISSWSH) annual meeting taking place
February 25 to 28 in Charleston,
South Carolina. The presentation concluded that, in a Phase 1
study, bremelanotide and ethanol can be safely co-administered and
are generally well tolerated with no reports of drug-related
serious adverse events. A total of twenty-four subjects were
enrolled, consisting of twelve women and twelve men.
Leonard R. DeRogatis, Ph.D.,
Director of the Maryland Center for Sexual Health and a consultant
to Palatin, presented an abstract titled "A placebo-controlled,
randomized, double-blind, three period, three-way crossover study
on the hemodynamic and pharmacokinetic interactions of
bremelanotide and ethanol."
Carl Spana, Ph.D., President and
CEO of Palatin, commented, "We are pleased to report the positive
results of this alcohol interaction study. Alcohol
interaction studies are required by the Food and Drug
Administration, and these results support our belief that there is
no adverse interaction between bremelanotide and alcohol use."
Top-line results of Palatin's ongoing Phase 3 clinical trials of
bremelanotide for female sexual dysfunction are on target for
release in the third quarter of calendar year 2016. Assuming
the Phase 3 trials are successful, Palatin will file a New Drug
Application with the FDA in the first half of calendar year
2017.
About Bremelanotide for Female Sexual Dysfunction
Palatin is developing bremelanotide as a subcutaneous, on-demand
treatment of female sexual dysfunction (FSD) in premenopausal women
diagnosed with hypoactive sexual desire disorder (HSDD).
Bremelanotide, which is a melanocortin agonist (a compound
which binds to a cell receptor and triggers a response) drug
candidate, is a synthetic peptide analog of the naturally occurring
hormone alpha-MSH (melanocyte-stimulating hormone).
Bremelanotide is an as-needed (not chronic), centrally-mediated
medication, unlike flibanserin (ADDYI®) or certain other
FSD treatments in development that require daily administration.
Studies have shown that bremelanotide starts working within 30 to
60 minutes of administration and remains effective for
approximately eight hours, providing women with control and
flexibility in their treatment as well as a quick response.
About Female Sexual Dysfunction
Female sexual dysfunction covers multi-factorial conditions that
have anatomical, physiological, medical, psychological and social
components. We plan to seek approval of bremelanotide for the
largest category of FSD, hypoactive sexual desire disorder
(HSDD).
HSDD is a medical condition marked by a lack of sexual thoughts
and desire for sexual activity, which causes a woman distress or
puts a strain on the relationship with her partner, and cannot be
accounted for by another medical, physical or psychiatric
condition, or as a result of other medication. It is estimated that
one in 10 women may have the signs of HSDD at some point in their
life, and as such HSDD represents a major opportunity to address a
tremendous medical need.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics 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 in order
to maximize their commercial potential. For additional information
regarding Palatin, please visit Palatin's website at
http://www.palatin.com.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin
Technologies, Inc. such as statements about clinical trial results
with bremelanotide, potential actions by regulatory agencies
relating to bremelanotide, potential labels and indications for
bremelanotide, and market potential for bremelanotide 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 nonclinical,
preclinical and toxicology studies, result of clinical trials,
regulatory actions by the FDA and the need for regulatory
approvals, regulatory actions by the USPTO, 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.
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SOURCE Palatin Technologies, Inc.