TORONTO, ONTARIO--(Marketwire - Dec. 6, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("the Company" or "Trimel") today announced that its Phase III pivotal clinical trial for CompleoTRT™ has met its primary efficacy endpoints. Based on these clinical results, Trimel will move forward to prepare for a meeting with the FDA and continue the process of completing its New Drug Application ("NDA") for filing with the United States Food and Drug Administration ("FDA").
The CompleoTRT™ Phase III clinical trial results demonstrated that after 90 days of product dosing, average serum testosterone levels for patients involved in the study were within FDA efficacy guidance for a testosterone replacement therapy. The Company's and external expert analysis of the Phase III clinical trial efficacy data is based on results from 306 patients who participated in the study. Safety data observed to this point is consistent with other testosterone therapies and no drug-related serious adverse events have been observed or reported. As originally agreed with the FDA, Trimel is collecting additional nasal safety data on patients who will have been administered CompleoTRT™ for up to 360 days as part of the NDA submission. Trimel expects to complete this in Q1 2013 and subsequently file the NDA with the FDA in an expeditious fashion.
CompleoTRT™'s unique intranasal no-touch delivery system is designed to provide patients with the therapeutic effect of supplementing testosterone levels with a small amount of drug as a bioadhesive intranasal gel.
According to IMS Health, nearly 5.8 million testosterone prescriptions were written in the first ten months of 2012, reflecting growth of 34% over the same period in 2011. This represents an acceleration of prescription growth rates as awareness of this medical condition by physicians and patients has increased.
Bruce D. Brydon, Chairman and CEO of Trimel, offered the following comment: "We believe that the results which we have announced today fully demonstrate that CompleoTRT™ can deliver testosterone effectively without the risk of transference and the use of time consuming and inelegant gel applications to various sites on the male body. Furthermore, study data to date demonstrates that the intranasal route of administration, and the pharmacokinetic profile which results, is safe, effective and fully differentiated from currently marketed testosterone products. Your company has accomplished much in its four year history, and I wish to thank our shareholders in helping us achieve this key milestone. We look forward to continuing to execute on our business plan in 2013."
CompleoTRT™ is designed to represent a significant advancement in the treatment of male hypogonadism, or low testosterone - commonly known as "Low T". CompleoTRT™'s unique delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bioadhesive intranasal gel.
CompleoTRT™'s intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (secondary transference) of testosterone to spouses or other family members, thus offering unique patient benefits and improved safety as compared to other currently marketed products indicated to treat "Low T". Since Trimel took over development in May 2009, CompleoTRT™ has been optimized to meet FDA regulatory requirements, including the development of a no-touch applicator device that is designed to ensure that CompleoTRT™ is dosed accurately and discretely.
About Hypogonadism ("Low T")
Subject to FDA approval, Trimel's lead product candidate, CompleoTRT™, would be indicated for the treatment of male hypogonadism or low testosterone - commonly known as "Low T." Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone levels that can be either acquired or inherited, and seriously affects the quality of life for those affected with the syndrome. Low testosterone is estimated to affect 13 million men in the United States, of which an estimated 90% go untreated. According to IMS Health, sales of marketed treatments for low testosterone in North America grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.
Trimel Pharmaceuticals Corporation (TSX:TRL) - Developing medications for Female Sexual Health and conditions related to Aging, and Well Being. Trimel is developing multiple product opportunities, including CompleoTRT™, a bioadhesive intranasal testosterone gel that has completed Phase III clinical efficacy testing in the United States. CompleoTRT™ is under investigation for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.trimelpharmaceuticals.com.
For further information regarding Trimel Pharmaceuticals Corporation, please contact either Bruce Brydon, Chairman of the Board and Chief Executive Officer at (416) 679-0711 or Kenneth Howling, Chief Financial Officer at (416) 679-0536 or via email at firstname.lastname@example.org.
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