Clinical-stage pharmaceutical company Adynxx has obtained the US Food and Drug Administration (FDA) fast track designation for its AYX1 injection, which is used for prevention of chronic pain.
In a five-cohort, dose-escalating study conducted in 30 healthy volunteers, AYX1 was well-tolerated at all dose levels with no serious adverse events.
Presently, the company is conducting a Phase II study designed to assess the safety and efficacy of AYX1 administered once before unilateral total knee arthroplasty (TKA) to reduce or prevent post-surgical pain in 90 patients.
Commenting on the designation, Adynxx regulatory affairs and product development vice president Scott Harris said, "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."
Adynxx chief medical officer Donald Manning added, "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."
