FDA Agrees to Review Intranasal Gel Testosterone Product
Approval decision expected in February 2014 (July 9)
The FDA has accepted a new drug application (NDA) for CompleoTRT (Trimel Pharmaceuticals), a bioadhesive intranasal gel testosterone product for hypogonadal patients. The NDA is supported by efficacy and safety results from 306 patients who participated in a pivotal phase III study.
The agency set a target action date of February 28, 2014.
Subject to FDA approval, CompleoTRT is designed to be applied to the interior lateral wall of the nasal cavity, where studies have shown that the gel is fully absorbed into the nasal mucosa within 15 to 30 minutes.
It is expected that, as a result of the “no touch” targeted delivery to the nasal mucosa, the product 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.
Source: Trimel Pharmaceuticals; July 9, 2013.