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**PKM-01** is an investigational intra-articular fixed-dose combination developed by PKMed for **acute gout flares**. It combines biodegradable PLGA microsphere-encapsulated, sustained-release **colchicine** with the fast-acting local anesthetic **ropivacaine**. Colchicine is intended to suppress local crystal-driven joint inflammation by disrupting tubulin-dependent microtubule function, while ropivacaine provides rapid local analgesia through voltage-gated sodium-channel blockade. In a rat acute inflammatory arthritis model, the combination reduced pain, joint inflammation, and histologic joint destruction while maintaining low systemic colchicine exposure. PKMed has stated that the program was cleared by FDA to enter directly into Phase 2 development under a 505(b)(2) regulatory pathway.
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