Trimel Pharmaceuticals has announced the acceptance of its NDA for CompleoTRT bioadhesive intranasal gel testosterone and the PDUFA date, February 28, 2014. The company announced submission of the NDA at the end of April 2013.
According to Trimel, CompleoTRT is an intranasal gel with no smell or taste, delivered using a multi-dose applicator, that will eliminate the potential of skin-to-skin transference that the FDA has identified as a risk for topical testosterone products. The company says that absorption takes place within 15-30 minutes.
Trimel is also developing a unit-dose DPI for both pulmonary and nasal delivery.
Read the Trimel press release.
