Trimel Gets FDA Approval For Natesto Gel
May 30th 2014
It has been announced today that the FDA has finally approved Natesto, a testosterone gel make by Trimel Pharmaceuticals..
Formerly known as CompleoTRT, the new formula is a self administered prescription gel which is applied by the use of a nasal applicator
It is thought that this new method of delivery will minimise the well publicised risk of secondary exposure of testosterone to both women and children.
The approval comes on the back of numerous lawsuits filed by users of other testosterone gels including Testim and Androgel.. the claimants have filed these lawsuits after suffering adverse health problems, some even suffering even heart attacks after using these products, they claim that the manufacturers failed to advise both the medical profession and themselves over the potential health risks that could be caused by the use of such products.
Natesto was evaluated by the FDA during a multicenter, open label 90 day trial involving 309 patients suffering with hypogonadism at 39 centers across the USA.
The average age of the patients was 54, but the overall ages ranged between 28 and 80.
They were treated with 33mg of Natesto daily and the results have returned some good results with over 80% showing improvements in testosterone levels after the 90 day period.
The long term effects of Natesto still remain unclear, and we believe that caution should still be exercised if you are prescribed this product by your doctor…