TORONTO, May 28, 2014 /PRNewswire/ -- Trimel
Pharmaceuticals Corporation (TSX: TRL) announced today top-line
results of its Phase II clinical trial evaluating the efficacy and
safety of Tefina™, a "use-as-required" testosterone nasal gel for
the treatment of Female Orgasmic Disorder (FOD). FOD, also known as
anorgasmia, is characterized by a delay, absence or reduced
intensity of orgasm, causing clinically significant distress.
The double-blind, placebo-controlled study enrolled 253 pre- and
post-menopausal women experiencing acquired FOD in the United States, Canada and Australia. Participants were randomized to one
of three dosage strengths (0.6 mg, 1.2 mg, 1.8 mg) or a placebo
group and treated over the course of 84 days. The primary endpoint
of the study was to compare the effects of the three dose strengths
of Tefina™ nasal testosterone gel to placebo on the occurrence of
orgasm. Secondary endpoints included the change from baseline in
distress due to orgasmic disorder, change in sexual functioning and
sexual event satisfaction. Safety and tolerability were also
assessed.
Tefina™ 0.6 mg led to a statistically significant increase in
the average number of orgasms during the 84-day treatment period of
2.3 versus 1.7 for the placebo arm (p=0.0015). In addition,
improvements in all of the secondary endpoints were observed;
however, further analysis is underway to assess statistical
significance. Tefina™ was found to be well-tolerated with no
reported serious adverse events.
"Female Orgasmic Disorder is the second most prevalent sexual
disorder affecting women. Approximately one in five women report
difficulty with orgasm and one quarter of these show marked
distress, a key criterion in a clinical diagnosis," said Dr.
Sheryl Kingsberg, the U.S. principal
investigator for the Tefina™ Phase II clinical trial, chief of
behavioral medicine at University Hospitals Case Medical Center and
professor of reproductive biology and psychiatry at Case Western Reserve University in Cleveland, Ohio. "Currently, there are no
approved pharmacological treatment options, leaving an unmet need
that Tefina™ hopes to remedy."
"These results mark an important milestone in the development of
Tefina™," said Tom Rossi, Trimel
President and CEO. "They provide further evidence that Tefina™
could represent an important treatment option for the many women
who suffer from this disorder. On behalf of Trimel and its various
stakeholders, I am extremely excited about this positive outcome
and look forward to advancing this product towards
commercialization."
Investor Event
Trimel is pleased to announce that it will host an Investor
Event on Thursday, June 12, 2014,
from 12:30 - 3:00 p.m. (Eastern Daylight
Time) to provide a more in-depth review of the Tefina™ Phase
II study results. Dr. Kingsberg, U.S. principal investigator for
the Tefina™ Phase II clinical trial, will be the keynote speaker at
the event. The Investor Event will be held at the Toronto Region
Board of Trade, First Canadian Place, Suite 350, 77 Adelaide Street
West, Toronto, Ontario and by
webcast. For more information or to register for the event, contact
rachael.factor@fleishman.ca or visit
http://trimelpharmaceuticals.com/Investors/Investor-Day. In-person
space is limited.
About Female Orgasmic Disorder
Female Orgasmic Disorder, also known as anorgasmia, is
characterized by a marked reduced intensity of orgasmic sensations,
or marked delay in, marked infrequency of, or absence of, orgasm
that has persisted for a minimum duration of approximately six
months, and causes clinically significant distress in the
individual. The diagnosis is further specified by whether the
dysfunction has been lifelong or acquired. Currently, there are no
approved treatments for Female Orgasmic Disorder.
About Trimel
Trimel is a specialty pharmaceutical company actively developing
medications for male hypogonadism, female sexual dysfunction and
various respiratory disorders. A New Drug Application for
CompleoTRT™, a product utilizing Trimel's licensed nasal gel
technology, has been filed with the United States Food and Drug
Administration and is awaiting regulatory approval. For more
information, please visit www.trimelpharmaceuticals.com.
Notice regarding forward-looking statements:
Information in this press release that is not current or
historical factual information may constitute forward-looking
information within the meaning of securities laws. Implicit in this
information are assumptions regarding our future operational
results. These assumptions, although considered reasonable by the
company at the time of preparation, may prove to be incorrect.
Readers are cautioned that actual performance of the company is
subject to a number of risks and uncertainties and could differ
materially from what is currently expected as set out above. For
more exhaustive information on these risks and uncertainties you
should refer to our annual information form dated March 5, 2014 which is available at
www.sedar.com. Forward-looking information contained in this press
release is based on our current estimates, expectations and
projections, which we believe are reasonable as of the current
date. You should not place undue importance on forward-looking
information and should not rely upon this information as of any
other date. While we may elect to, we are under no obligation and
do not undertake to update this information at any particular time,
whether as a result of new information, future events or otherwise,
except as required by applicable securities law.
SOURCE Trimel Pharmaceuticals Corporation