Trimel Pharmaceuticals announced that the FDA has approved Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism.
Natesto was evaluated in a Phase 3 multicenter, open-label, 90-day trial that enrolled 306 hypogonadal men. During the Natesto treatment period (Days 1–90), 78 patients were treated with 33mg testosterone daily. Of these, a total of 73 men were included in the statistical evaluation of efficacy on Day 90 based on the intent-to-treat (ITT) population with last observation carried forward (LOCF).
Ninety percent (90%) of these patients had Cavg within the normal range (300–1050ng/dL) on Day 90. The percentage of patients with Cavg below the normal range (<300ng/dL) on Day 90 was 10% and no subject had a Cavg value exceeding 1050ng/dL.
Natesto is applied via nasal applicator which help reduce the risk of secondary exposure to testosterone of women or children. Natesto will be available as a metered-dose pump that delivers 5.5mg testosterone per pump.
For more information call (416) 679-0771 or visit Trimelpharmaceuticals.com.