CRANBURY, N.J., Aug. 18, 2015 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical needs and
commercial potential. Palatin's lead product under development is
bremelanotide for the treatment of female sexual dysfunction
(FSD).
The approval of flibanserin (under development by Sprout
Pharmaceuticals) today by the U.S. Food and Drug Administration
(FDA) marks a long-awaited milestone in healthcare for women.
The FDA's approval of flibanserin validates that there is an
important need for women living with hypoactive sexual desire
disorder, or HSDD, to have an approved treatment option. Palatin
applauds the FDA's positive determination, which supports FDA's
previous statements that HSDD is an unmet medical need requiring a
safe treatment option for women with 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 with therapies like flibanserin and
bremelanotide.
Palatin Technologies is continuing the development of
bremelanotide, a first-in-class, as needed, melanocortin-4 receptor
agonist being studied for the treatment of HSDD in pre-menopausal
women, so that these women suffering from HSDD have multiple
treatment options in the future. Bremelanotide has a novel
mechanism that activates endogenous pathways in the brain involved
in creating a sexual response. Unlike flibanserin or certain other
FSD treatments in development that require daily administration,
bremelanotide is an as-needed (not chronic), centrally-mediated
medication. Studies have shown that bremelanotide starts working
within 30 to 60 minutes of administration and remains effective for
approximately eight hours, providing women with greater control and
flexibility in their treatment as well as a quick response. By
comparison, flibanserin must be taken daily and may take up to
several weeks of continuous daily use before an effect of increased
sexual desire is seen. The differing dose frequency and route of
administration, if available in the marketplace at the same time,
could provide a robust set of treatment options for women suffering
from HSDD.
Palatin Technologies is excited to continue working toward
bringing bremelanotide as a treatment for HSDD closer to a reality,
expanding the HSDD marketplace and providing women with multiple
options. Palatin Technologies is currently enrolling
pre-menopausal women with HSDD into its Phase III trials for
bremelanotide, and anticipates completing enrollment for the trials
by the end of this year. Each pivotal trial of the reconnect
study is a multicenter (~80 sites), randomized, placebo
controlled, parallel-group, eight month trial with an open-label
extension phase. The clinical trials are designed to randomize
approximately 1100 women (~550 each trial) to evaluate the efficacy
and safety of subcutaneous bremelanotide in premenopausal women
with hypoactive sexual desire disorder (HSDD) as an on-demand,
as-needed treatment. More information on the trial protocol,
including trial design and inclusion/exclusion criteria, can be
found at http://clinicaltrials.gov.
About Bremelanotide for Female Sexual
Dysfunction
Palatin is developing bremelanotide subcutaneous
for the treatment of FSD in premenopausal women diagnosed with FSD.
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).
About Female Sexual Dysfunction
Female Sexual
Dysfunction covers multi-factorial conditions that have anatomical,
physiological, medical, psychological and social components.
We will seek approval of bremelanotide for the largest
category of FSD, hypoactive sexual desire disorder. To
establish a diagnosis of FSD, one or more of the disorders making
up FSD must be associated with personal distress, as determined by
the affected women.i A study of more than
30,000 U.S. women in 2008 reported an age-adjusted point prevalence
of sexual difficulties causing personal distress in 12 percent of
respondents.ii
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 potential clinical trial results with
bremelanotide, potential actions by regulatory agencies in
the United States or Europe relating to bremelanotide, regulatory
plans, development programs and the market potential of
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, the ability
of Palatin to enter into one or more agreements relating to the
commercialization of bremelanotide, results of nonclinical,
preclinical and toxicology studies, result of clinical trials,
regulatory actions by the FDA and other regulatory agencies 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.
i Frank J et al. Diagnosis and Treatment of Female
Sexual Dysfunction. AmFam Physician 2008; 77(5):
635-642.
ii Shifren JL et al. Sexual Problems and Distress in
United States Women: Prevalence
and Correlates. ObstetGynecol 2008;112 (5); 968-9.
Logo - http://photos.prnewswire.com/prnh/20150212/175291LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/palatin-technologies-supports-fdas-approval-of-the-first-ever-treatment-for-female-sexual-dysfunction-300130413.html
SOURCE Palatin Technologies, Inc.