Trimel Pharmaceuticals Corporation announced today that the Company has submitted a New Drug Application to the United States Food and Drug Administration 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.