Aytu BioScience is a specialty pharmaceutical company focused on developing and commercializing novel products in the field of urology. Aytu is initially concentrating on hypogonadism, prostate cancer, male infertility, and plans to expand into other urological indications for which there are significant medical needs.
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 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 worldwide, and oxidative stress is widely implicated in its pathophysiology.
The company’s most advanced development therapeutic is Zertane™, an oral, Phase 3-ready treatment being studied for the treatment of premature ejaculation (PE). PE is the most common sexual dysfunction for which there is not an FDA approved treatment and affects up to 22% of men. Zertane, which has demonstrated safety and efficacy in two European pivotal studies, has the potential to be the first oral therapeutic approved in the United States for the treatment of PE.