Lipocine Inc. Oral Testosterone Replacement Product Cleared by FDA for Phase III Study
12/6/2012 11:32:26 AM
SALT LAKE CITY--(BUSINESS WIRE)--Lipocine Inc. (www.lipocine.com) announced today that the Company recently met with the FDA and received guidance and go-ahead for the Company’s pivotal Phase III study for its oral testosterone replacement therapy (LPCN 1021). Lipocine presented the results of its Phase II trials to the FDA that indicated LPCN 1021 exceed both Primary and Secondary endpoints that are required according to FDA criteria for approval. As a result of the meeting, Lipocine is preparing plans to initiate its Phase III study.