Aytu BioScience is a specialty pharmaceutical company focused on developing and commercializing novel products in the field of urology. Aytu is initially concentrating on prostate cancer, male sexual dysfunction and male infertility and plans to expand into other urological indications for which there are significant medical needs.
The company currently 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. Aytu also markets Primsol® (trimethoprim hydrochloride) – the only FDA-approved trimethoprim-only oral solution for urinary tract infections.
The company’s most advanced therapeutic is Zertane™, an oral therapeutic entering Phase 3 clinical studies in the United States as an as needed treatment for 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.
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 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®.