Adynxx announced completion of patient enrollment in a Phase 2 clinical study for AYX1 for the 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.
This seven-center, randomized, placebo-controlled study in 102 patients 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 will follow patients for 42 days, with a primary endpoint of pain with walking.
In July 2013, the FDA granted AYX1 Injection Fast Track designation for the prevention of chronic pain.
For more information call (415) 512-7740 or visit Adynxx.com.