TORONTO, May 28, 2014 /PRNewswire/ -- Trimel Pharmaceuticals Corporation (TRL.TO) 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."
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 [email protected] 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.
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.