Trimel receives FDA approval for Natesto Nasal Gel male low testosterone
The FDA has approved Trimel Pharmaceuticals’ Natesto (testosterone), formerly CompleoTRT, a testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator, thereby minimizing the risk of secondary exposure to testosterone of women or children.
"In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages," said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida (CRSA). "For these patients seeking to restore their testosterone levels, Natesto will offer an alternative delivery system that is safer and more convenient than the other options currently available on the market."
It is conservatively estimated that nearly 13 million American men may have low testosterone levels. Current treatment guidelines focus on the restoration of the physiological testosterone level through the use of exogenous testosterone preparations, which include topical gels applied by the hands, subcutaneous pellets, transdermal patches, intramuscular injections, oral tablets and a buccal patch.
Natesto was evaluated in a multicenter, open-label, 90-day phase III trial that enrolled 306 hypogonadal men at 39 clinical research centers in the U.S. The mean age of patients was 54 years with a range of 28 to 80 years. Of the 306 patients, 271 (89%) were Caucasian, 18 (6%) were African-American, 16 (5%) were Asian and one (less than 1%) had race recorded as "Other." During the Natesto treatment period (days one to 90), 78 patients were treated with 33mg of 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 of these patients had C(avg) within the normal range (300 to 1050ng/dL) on day 90. The percentage of patients with C(avg) below the normal range (less than 300ng/dL) on day 90 was 10% and no subject had a C(avg) value exceeding 1050ng/dL.