|By Marketwired .||
|June 16, 2014 06:00 AM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 06/16/14 -- Trimel Pharmaceuticals Corporation (TSX: TRL) reported results from further analysis 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).
Tefina 0.6 mg showed a 35% increase in the average number of orgasms versus placebo (p=0.0013) and 58% of women had at least one orgasm, compared to 43% of women in the placebo group. The median number of orgasms achieved was two for Tefina 0.6 mg versus zero in the placebo group.
Secondary endpoints for the trial included the assessment of changes from baseline in distress, sexual event satisfaction and sexual functioning. Note that the trial was not powered to demonstrate statistical significance for the secondary endpoints.
-- Tefina 0.6 mg showed a measurable improvement in distress over placebo (1.3 for Tefina 0.6 mg, 0.9 for placebo, p=0.14). Of note, the difference from placebo steadily increased over the 84-day treatment period. The reported change in distress from baseline achieved statistical significance (pless than 0.001). -- The mean score for sexual event satisfaction (SES) improved from 1.09 for placebo to 1.38 for Tefina 0.6 mg (p=0.3). A 25% increase in the total number of sexual events for Tefina 0.6 mg relative to placebo was also observed. -- Global Sexual Function (GSF) showed measurable improvement for Tefina at all dose strengths and in all domains of sexual function (e.g. arousal, desire, lubrication orgasm, satisfaction and pain). The strongest improvements reported were observed in the orgasm domain of GSF with Tefina 0.6 mg.
At study completion, 45% of patients responded "yes" when asked if Tefina 0.6 mg provided a meaningful improvement in their ability to achieve orgasm (p=0.17) . When asked if, as a result of treatment with Tefina 0.6 mg, the change in orgasm was a meaningful benefit, 47% responded "yes" (p=0.3).
Tefina was found to be well-tolerated with no reported serious adverse events.
"These additional observations provide further positive support for Tefina 0.6 mg as a potential treatment for the many women suffering from female orgasmic disorder," stated Tom Rossi, President and Chief Executive Officer of Trimel. "Once our analysis is complete, we hope to meet with the United States Food and Drug Administration to determine the next steps to advance the clinical development of this exciting opportunity."
About Tefina AMB-2012-01 Phase 2 Clinical Study
AMB-2012-01 was a double-blind, placebo-controlled study having 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 measures of distress, sexual event satisfaction and global sexual function using standardized questionnaires administered monthly and after 84 days of treatment. Distress was quantified using the Female Sexual Distress Scale specific for Female Desire Arousal Orgasm (FSDS-DAO). Sexual Event Satisfaction (SES) was measured by the MONASH Female Sexual Satisfaction Questionnaire (MONASH FSSQ). Global Sexual Function (GSF) was measured using the total score from the Female Sexual Function Index.
Trimel held an Investor Event on Thursday, June 12, 2014 at the Toronto Region Board of Trade. A webcast of this event will be available at http://trimelpharmaceuticals.com/ Investors/Investor-Day.
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. Natesto, a product utilizing Trimel's licensed nasal gel technology, has approved for sale in the United States by the FDA. 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.
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