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OMS201 is a proprietary combination irrigation solution developed by Omeros Corporation for use during urological procedures, specifically ureteroscopy for the removal of ureteral or renal stones (urolithiasis). The drug contains two active pharmaceutical ingredients: ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), and nifedipine, a smooth muscle relaxant and calcium channel blocker. OMS201 is added to standard irrigation solution and delivered directly to the surgical site during uroendoscopic procedures to inhibit surgically induced inflammation, pain, and smooth muscle spasms (ureteral spasms). The program completed a Phase 1/2 clinical trial that evaluated its pharmacokinetics, safety, and efficacy, demonstrating that the solution was well tolerated with minimal systemic absorption. However, development was subsequently suspended by Omeros due to limited clinical development resources, with the company exploring alternative commercialization approaches such as distribution through registered outsourcing facilities.
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