Acerus Pharmaceuticals Corporation announced the Health Canada approval of NATESTO, the first and only nasal gel for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO is the lowest dose testosterone gel replacement therapy to be approved in Canada, with the majority of men achieving normal testosterone levels in a Phase III study. In addition, NATESTO demonstrated significant improvements in erectile function, intercourse satisfaction, orgasmic function, sexual desire, overall satisfaction and positive mood versus baseline.
The product utilizes a bioadhesive nasal gel technology, allowing for convenient, no-touch' administration within seconds, rapid absorption and reduced risk of secondary transference to women and children. NATESTO has a recommended twice-daily starting dose, which can be adjusted up to a three times daily dose if needed. NATESTO is expected to be commercially available in Canada by mid-2016.