Lipocine Says FDA Recommends Removing Cardiovascular Risk Warning From Testosterone Product Labels

(RTTNews) - Biopharmaceutical company Lipocine, Inc. (LPCN) announced Wednesday that the U.S. Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes.

This decision follows the Agency's review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the results from required post market ambulatory blood pressure (ABPM) studies.

Based on the TRAVERSE trial results, the FDA has recommended that the Boxed Warning related to an increased risk of adverse cardiovascular outcomes be removed from the labels of testosterone products.

Additional recommendations include adding the results of the TRAVERSE trial to all testosterone products and retaining "Limitation of Use" language for age-related hypogonadism.

The FDA is also requiring all labels to include product-specific information on increased blood pressure for testosterone products based on the results of ABPM studies.

Lipocine has an exclusive license agreement with Verity Pharma (entered into in 2024) under which Verity Pharma has the rights to market its testosterone replacement therapy product in the United States and also in Canada, if approved.