FDA CRL - Antares Pharma, Inc

Antares Pharma, Inc. received a Complete Response Letter from the FDA regarding its New Drug Application (NDA 209863) for testosterone enanthate subcutaneous injection, submitted on December 20, 2016, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The primary concerns stem from the product's safety profile, specifically clinical data indicating a potential for clinically meaningful increases in blood pressure, with a significant percentage of patients experiencing elevated systolic pressure. The FDA is concerned these findings, from a largely normotensive population, may underestimate cardiovascular risks in a real-world setting. Additionally, the development program reported cases of suicide attempts and depression, for which drug causality could not be excluded.

To resolve these issues, Antares Pharma is required to conduct a new Ambulatory Blood Pressure Monitoring (ABPM) study. This study must further characterize the product's effects on blood pressure and cardiovascular risk in a patient population more consistent with real-world use, including collecting data on other cardiovascular parameters. A plan must also be proposed to address the suicidality signal, potentially through periodic psychiatric evaluations within the new ABPM study. Other required actions include submitting updated prescribing and carton/container labeling, resubmitting the proposed proprietary name, and providing a comprehensive safety update.