Hanmi Pharmaceutical presents Naxozol Phase 3 results for low back pain

Hanmi Pharmaceutical presented Phase 3 clinical trial results for its combination drug, Naxozol (naproxen and esomeprazole), at the International Society of Orthopaedic Surgery and Traumatology (SICOT) congress held in Kyoto, Japan.

Professor Son Hee-jung of Nowon Eulji University Hospital presented the findings, which demonstrated that Naxozol provides pain relief for chronic low back pain comparable to naproxen monotherapy while offering superior gastrointestinal safety. The study was a randomized, double-blind, multicenter, non-inferiority trial.

Naxozol is noted as the only combination product of its kind to secure an indication for low back pain. Following these clinical results, the South Korean Ministry of Food and Drug Safety had previously approved the addition of low back pain to the drug's existing indications, which include osteoarthritis and ankylosing spondylitis.