CompleoTRTTreatment for Hypogonadism -- Male
United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT
TORONTO, ONTARIO--(Marketwired - July 9, 2013) - Trimel Pharmaceuticals Corporation today announced that the New Drug Application ("NDA") for its bioadhesive intranasal gel testosterone product ("CompleoTRT") has been formally accepted for review by the United States Food and Drug Administration (the "FDA"). The NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.
Additionally, the FDA has confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014.
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.
Subject to FDA approval, CompleoTRT is designed to be applied to the interior lateral wall of the nasal cavity, where internal studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the "no touch" targeted delivery to the nasal mucosa, CompleoTRT should avoid skin-to-skin transference to spouses or other family members, a health risk that led the FDA to issue a "black-box" warning in May 2009 for secondary transference for all topical testosterone gel preparations.
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.
Source: Trimel Pharmaceuticals Corporation
Posted: July 2013