TORONTO, Canada I April 30, 2013 I Trimel Pharmaceuticals Corporation (TRL.TO) (the “Company” or “Trimel”) proudly announced today that the Company has submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for approval of its bioadhesive intranasal gel testosterone product, indicated for the treatment of testosterone deficiency in men (“CompleoTRT™”). The CompleoTRT™ NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.
“This NDA filing is an important achievement for Trimel,” said Tom Rossi, President and Chief Executive Officer of Trimel. “If approved, CompleoTRT™ will provide men suffering from “Low T” with a novel treatment option. CompleoTRT™ is expected to offer hypogonadal patients the lowest efficacious delivered dose of testosterone in a convenient discreet device, without the risk for secondary transference.”
The Company expects the CompleoTRT™ NDA will be subject to a standard review by the FDA, which could be completed as early as the first half of 2014.
About CompleoTRT™
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.
About Trimel
Trimel Pharmaceuticals Corporation (TRL.TO) – Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. For more information, please visit www.trimelpharmaceuticals.com.
SOURCE: Trimel Pharmaceuticals
Post Views: 87
TORONTO, Canada I April 30, 2013 I Trimel Pharmaceuticals Corporation (TRL.TO) (the “Company” or “Trimel”) proudly announced today that the Company has submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for approval of its bioadhesive intranasal gel testosterone product, indicated for the treatment of testosterone deficiency in men (“CompleoTRT™”). The CompleoTRT™ NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.
“This NDA filing is an important achievement for Trimel,” said Tom Rossi, President and Chief Executive Officer of Trimel. “If approved, CompleoTRT™ will provide men suffering from “Low T” with a novel treatment option. CompleoTRT™ is expected to offer hypogonadal patients the lowest efficacious delivered dose of testosterone in a convenient discreet device, without the risk for secondary transference.”
The Company expects the CompleoTRT™ NDA will be subject to a standard review by the FDA, which could be completed as early as the first half of 2014.
About CompleoTRT™
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.
About Trimel
Trimel Pharmaceuticals Corporation (TRL.TO) – Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. For more information, please visit www.trimelpharmaceuticals.com.
SOURCE: Trimel Pharmaceuticals
Post Views: 87
