The agency concurs that a single Phase III pivotal trial should provide confirmatory evidence if the clinical and statistical benefits shown in the study are compelling.
Jack Stover, president and CEO of Antares Pharma, said: “Having a clear and defined registration path in Europe makes our testosterone ATD Gel for hypoactive sexual disorder disease (HSDD), an attractive product for potential commercial partners that serve the patient population suffering from hypoactive sexual desire disorder and related female sexual dysfunction (FSD).”