Aytu BioScience is initially concentrating on prostate cancer, male sexual dysfunction and male infertility and will expand into other urological indications through acquisition or licensing of approved, commercialized products and late-stage development assets.
The company currently markets Natesto® (testosterone) nasal gel, the only FDA-approved nasally administered testosterone. Natesto is an androgen indicated for replacement therapy in adult males with a deficiency or absence of endogenous testosterone due to primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism.
Aytu also markets ProstaScint® (capromab pendetide), the only radioimaging agent indicated to detect prostate specific membrane antigen (PSMA) in the assessment and staging of prostate cancer. ProstaScint is FDA-approved for use in both newly diagnosed, high-risk prostate cancer patients and patients with recurrent prostate cancer.
Additionally, Aytu markets Primsol® (trimethoprim hydrochloride) – the only FDA-approved trimethoprim-only oral solution for the treatment of urinary tract infections.
Aytu is also conducting 510(k) clinical trials with the company’s MiOXSYS™ system as a novel, point-of-care semen analysis system with the potential to become a standard of care in the diagnosis and management of male infertility. Male infertility is a prevalent and underserved condition and oxidative stress is widely implicated in its pathophysiology. MiOXSYS was developed from the company’s core oxidation-reduction potential research platform known as RedoxSYS®.