|By Marketwired .||
|January 14, 2014 05:00 PM EST||
TORONTO, ONTARIO -- (Marketwired) -- 01/14/14 -- Trimel Pharmaceuticals Corporation (TSX: TRL) is pleased to announce that it has completed enrollment of its ongoing Tefina Phase II clinical trial. Tefina is being developed and clinically tested as a possible treatment for women suffering from Female Orgasmic Disorder.
Participants enrolled in this trial are required to undergo a 28-day screening/baseline period as defined by the trial protocol. During this period, participants are required to have a minimum of four sexual events. Women who experience an absence of orgasm during this baseline period and meet all other trial criteria are then permitted to continue in the study. These women are randomized into one of four treatment arms and then continue treatment for a period of 84 days. The primary efficacy variable for the trial is the number of orgasms following administration of each of the dosage strengths of Tefina compared to placebo over the entire treatment period.
The Tefina ambulatory clinical trial is being conducted primarily in the United States as well as in Australia and Canada. Trimel anticipates having top-line data available from this trial in the second quarter of this year.
"This is an important clinical trial for Trimel and may be of significance for the millions of women who suffer from this serious condition," stated Tom Rossi, President and Chief Executive Officer. "We look forward to the completion of this clinical trial and disclosing the results in due course."
Trimel's product candidate Tefina is a bioadhesive "no touch" intranasal low-dose gel formulation of testosterone. Tefina is being developed to offer women with Female Orgasmic Disorder, a "use as required" treatment option. Tefina is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the proposed dispenser.
About Female Orgasmic Disorder
Female Orgasmic Disorder is defined as the persistent or recurrent delay in, or absence of, orgasm following normal sexual excitement phase that causes marked personal distress or interpersonal difficulties. The etiology of Female Orgasmic Disorder is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary). This condition is believed to affect one in five pre and post menopausal women worldwide. Currently there are no approved treatments for Female Orgasmic Disorder and this therefore represents an unmet need for women suffering distress from this condition.
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 bioadhesive intranasal gel technology, has been filed with the United States Food and Drug Administration for regulatory approval in the United States. 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, including whether the Company will be successful in developing and clinically testing products under development (including Tefina) and that CompleoTRT may not be approved by the FDA or that any approval may be delayed, 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 prospectus dated April 18, 2013 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.