TORONTO--(BUSINESS WIRE)--Trimel Pharmaceuticals Corporation (TSX:TRL) today communicated its support of the U.S. Food and Drug Administration’s (FDA) decision to approve ADDYITM (flibanserin; developed by Sprout Pharmaceuticals), the first treatment option for female sexual dysfunction (FSD). Trimel is currently developing TEFINATM, a ‘use as required’, low-dose nasal testosterone gel treatment for female orgasmic disorder, a subset of FSD.
“Trimel commends the FDA on their landmark decision. Women experiencing hypoactive sexual desire disorder in the U.S. will finally have an approved treatment option,” said Tom Rossi, President and Chief Executive Officer of Trimel. “This approval demonstrates the FDA’s recognition of this important medical unmet need, and their commitment to encouraging drug development for FSD. In addition, this approval provides further support for the clinical and regulatory development strategy for TEFINATM.”
Female orgasmic disorder (FOD) is characterized by a persistent difficulty experiencing orgasm and/or markedly reduced intensity of orgasmic sensations. In a survey of over 1,700 women aged 18 to 59, 43% acknowledged some form of sexual dysfunction. The data suggests that 32% of the women lacked interest in sex and 26% could not experience orgasm.1 Currently, there are no approved treatments for FOD.
Earlier this month, Trimel met with the FDA to discuss the next clinical study for TEFINA™, and looks forward to continuing to advance the product through its development program.
About Trimel
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, including with respect to the further development of TEFINA™, 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 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.
1 Laumann et al. Sexual dysfunction in the United States: Prevalence and predictors. Journal of the American Medical Association. April 1999.
