Palatin female sexual
desire drug succeeds in trials; shares soar
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[November 02, 2016]
By Bill Berkrot
(Reuters) - A drug meant to boost the
libido of pre-menopausal women distressed by lack of sexual desire met
the main goals of a pair of late stage clinical trials, according to
initial results released on Tuesday by its developer, Palatin
Technologies Inc <PTN.A>, and its shares rose 66 percent.
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Palatin said the experimental drug, bremelanotide, demonstrated
statistically significant improvement versus placebo on scales
measuring levels of desire and distress in 24-week studies of more
than 1,200 women diagnosed with hypoactive sexual desire disorder (HSDD).
"The distress component of HSDD reflects the profound negative
impact that this condition can have on women's' self-image,
relationships and quality of life well outside the bedroom," Sheryl
Kingsberg, one of the study's investigators, said in a statement.
"In the Phase 3 trials we saw significant reduction in distress with
use of bremelanotide," added Kingsberg, a professor of reproductive
biology at Case Western Reserve University School of Medicine in
Ohio.
Shares of tiny Palatin rose to 80 cents in after hours trading from
their close at 48 cents.
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The drug was well tolerated with no new safety issues identified,
Palatin said. The most frequent side effect was nausea, which was
generally mild.
While drugs attempting to address this disorder are often referred
to as "female Viagra," Palatin's is more like Viagra in that it is
designed to be taken as needed in anticipation of sexual activity,
rather than every day. However, it is not a pill but administered
subcutaneously via autoinjector.
The drug is a synthetic peptide analog that mimics a naturally
occurring hormone.
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Palatin expects to file with regulators seeking U.S. approval for
bremelanotide in the second half of 2017.
If approved, it would compete with the controversial Addyi, which
was approved in August under intense pressure from patient advocacy
groups and is sold by Valeant Pharmaceuticals International.
Addyi, which has sold poorly, carries a boxed warning saying it can
cause fainting and extremely low blood pressure and that it should
not be used with alcohol.
(Reporting by Bill Berkrot; Editing by Steve Orlofsky)
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