FDA Grants Fast Track Designation to Adynxx Lead Compound AYX1 AYX1 Injection Designated as a Fast Track Development Program for Prevention of Chronic Pain
SAN FRANCISCO, July 17, 2013 /PRNewswire/ -- Adynxx, a clinical-stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AYX1 Injection for the prevention of chronic pain.
"Fast Track designation for the AYX1 program is an important acknowledgement by the FDA of the need for advancements in the prevention of chronic pain," said Rick Orr, CEO of Adynxx. "We will continue to advance the development of AYX1 as rapidly as possible for the benefit of patients who are in need of new treatment options for post-surgical pain."
"We are pleased to receive the Fast Track designation," added Scott Harris, vice president of regulatory affairs and product development at Adynxx. "The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs."
In September 2012 Adynxx completed a 30-subject, dose-escalating study of AYX1 in five cohorts of healthy volunteers. AYX1 was well-tolerated at all dose levels, with no serious adverse events reported and no subjects withdrawing from the study. Adynxx is currently enrolling a 90 patient placebo-controlled Phase 2 study to evaluate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce or prevent post-surgical pain.
"While many widely-used pain therapies require repeat dosing for symptom relief, a single administration of AYX1 has the potential to prevent the development of pain before it begins," said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. "The fact that the FDA has granted Fast Track designation for the prevention of chronic pain recognizes an important aspect of the unique profile of AYX1, which we believe will transform the treatment of post-surgical pain."
Adynxx, located in San Francisco, California, is a clinical stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots - preventing the development of pain following surgery or trauma and resolving established chronic pain syndromes. Adynxx's unique approach is to transform pain management by approaching pain as a disease rather than a symptom.
Adynxx's lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery.
Funded by Domain Associates, Adynxx has successfully completed a Phase 1 clinical trial of AYX1 and initiated a Phase 2 study of AYX1 in Q1 2013. Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical discovery stage.