TORONTO, ONTARIO--(Marketwired - Jan. 17, 2014) - Trimel Pharmaceuticals Corporation (TSX:TRL) today announced that the United States Food and Drug Administration ("FDA") has decided to extend the Prescription Drug User Fee Act (PDUFA) target action date for the CompleoTRT™ new drug application ("NDA") from February 28, 2014 to May 28, 2014. This will provide the FDA with the required time for a full review of the submission in light of the previously announced decision by the Company to amend its proposed label.
"As the FDA considered the change in labelling a major amendment, we understand that this extension is consistent with their normal practices in these circumstances," stated Tom Rossi, President and Chief Executive Officer. "We will continue to work closely with the FDA in order to obtain approval for this important therapy as quickly as possible."
Trimel's most advanced product candidate, CompleoTRT™, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT™ is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.
Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT™, a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA 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.