In This Article:
SALT LAKE CITY, March 12, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced 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.
"We are excited about these label changes, including the removal of the Boxed Warning, as we expect the changes to be beneficial to our approved testosterone replacement therapy product as well as for our obesity management and liver disease development candidates," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "With this important regulatory update, developers and regulators can now be guided by the updated evidence-based labels, ensuring that both the benefits and risks of testosterone are considered."
The company 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. Lipocine's pipeline also includes additional unique testosterone-based product candidates including: LPCN 2401 (in development for obesity management), LPCN 1148 (in development for management of liver cirrhosis), and LPCN 1144 (in development for metabolic dysfunction-associated steatohepatitis (MASH)).
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.