The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lipocine Inc.’s LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis.
 
LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept (POC) Phase 2 study in patients with decompensated cirrhosis.  Treatment with LPCN 1148 in the POC study improved sarcopenia and associated clinical outcomes.  LPCN 1148 is targeted to be a “First in Class” product candidate with a novel mechanism of action for management of cirrhosis.
 
“We are excited the FDA has recognized that sarcopenia in patients with cirrhosis is a serious condition and that LPCN 1148 has the potential to provide clinical benefits for these patients where no therapy currently exists,” said Dr. Mahesh Patel, President and CEO of Lipocine. “We are encouraged that the positive primary endpoint results from our successful proof-of-concept study were recognized by the FDA as evidence of clinical effectiveness of LPCN 1148 in improving sarcopenia in patients with cirrhosis.”
 
The Fast Track program is designed to accelerate the development and expedite the review of products, such as LPCN 1148, which are intended to treat serious diseases and for which there is an unmet medical need.