TORONTO--(BUSINESS WIRE)--Trimel Pharmaceuticals Corporation (TSX:TRL) today reported that it has scheduled a consultation meeting with the U.S. Food and Drug Administration (FDA) to be held in August to discuss TEFINA™, a “use as required” nasal testosterone gel in development for female orgasmic disorder. Building on the FDA feedback received earlier this year, the objective will be to review and solicit comments on the draft protocol for a subsequent study in the TEFINA™ clinical program.
“This consultation meeting is a key step required to advance the regulatory status for TEFINA™, and should provide the FDA guidance needed to refine and implement our development strategy,” said Tom Rossi, President and CEO of Trimel. “We are proud to be a part of the important scientific research and broader dialogue bringing much needed awareness, as well as a potential new treatment option, to the many women experiencing orgasmic disorder.”
About Female Orgasmic Disorder
Female orgasmic disorder (FOD) 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 FOD.
Trimel is a Canadian pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience.
Trimel markets ESTRACE® in Canada, a product indicated for the symptomatic relief of menopausal symptoms. NATESTO™, a product utilizing Trimel's licensed nasal gel technology, is the first and only testosterone nasal gel approved and launched in the United States for replacement therapy in adult males diagnosed with hypogonadism, and is currently filed for approval in Canada. The commercial rights to NATESTO™ in the United States and Mexico have been licensed by Trimel to an affiliate of Endo International plc. TEFINA™, a “use as required” nasal testosterone gel, is Trimel’s drug development candidate aimed at addressing a significant unmet need for women with female orgasmic disorder.
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 with respect to the development of TEFINA™ 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 4, 2015 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.