TORONTO, ONTARIO--(Marketwired - Dec. 19, 2013) - Trimel Pharmaceuticals Corporation (TSX:TRL) today announced an update regarding its recent discussions with the United States Food and Drug Administration ("FDA") relating to its new drug application for CompleoTRT™ submitted earlier this year.
As a result of such discussions, the Company believes that the most expeditious basis for seeking an FDA approval is to proceed with a proposed three-times-a-day ("TID") dosing protocol for CompleoTRT™. Accordingly, the Company is in the process of amending its proposed label to reflect a TID-only dosing regimen. However, there are no assurances that such an approach will result in approval of CompleoTRT™.
"Following a constructive dialogue with FDA staff, the Company has elected to proceed with TID dosing as the basis of seeking an expeditious approval for CompleoTRT™," stated Tom Rossi, President and Chief Executive Officer. "The Company continues to believe that a twice-per-day dose represents a promising alternative for patients with hypogonadism and we are considering options for pursuing approval for such a dosing regimen."
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 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.