TKAine

TKAine (also known as ATX-101) is an investigational, bioresorbable, ultra-sustained drug-device combination implant designed to provide localized, non-opioid postsurgical analgesia following total knee arthroplasty (TKA). Developed by Allay Therapeutics (originally incubated by The Foundry), the system consists of a compressed polymeric film composed of bupivacaine—a well-characterized voltage-gated sodium channel blocker—embedded within a biodegradable poly(lactic-co-glycolic acid) (PLGA) matrix. Placed directly into the surgical site by the orthopedic surgeon at the conclusion of TKA, TKAine is engineered to deliver a controlled release of bupivacaine over a 14-day period, targeting the critical post-operative window where breakthrough pain is most intense and reducing the reliance on systemic opioids. The implant naturally erodes and dissolves into water and carbon dioxide within 12 weeks. TKAine has been granted Breakthrough Therapy Designation by the FDA and is currently being evaluated in Phase 2b clinical trials.

Brand names

TKAine

Other names

TKAine SystemTKAine bupivacaine implant