Adynxx announced the completion of enrollment in a Phase 2 clinical study of its lead product candidate, AYX1, for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery. The company said that U.S. Food and Drug Administration (FDA) granted Fast Track designation to AYX1 Injection for the prevention of chronic pain in July 2013. The company said that 102-subject, seven-center, randomized, placebo-controlled study is currently evaluating the safety and efficacy of a single intrathecal administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce acute pain and to prevent the transition to persistent pain.

The study is following subjects for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory endpoints include pain at rest, pain with knee range of motion, rate and extent of functional recovery, opioid consumption and safety assessments.