OMS201 is being developed for use during urological procedures. OMS201 is a proprietary combination of an anti-inflammatory agent and a smooth muscle relaxant. Both active agents are contained in generic, FDA-approved drugs with well-known profiles of safety and pharmacologic activities, and each is contained in drugs that have been marketed in the U.S. for more than 15 years.

Added to standard irrigation solutions in urological procedures, OMS201 is delivered directly to sites of inflammation or surgical procedures. For example, OMS201 may be used during uroendoscopic procedures, such as bladder endoscopy, minimally invasive prostate surgery and ureteroscopy, to inhibit surgically induced inflammation, pain and smooth muscle spasm.

We have completed a Phase 1 clinical trial that evaluated the safety and systemic absorption of OMS201 added to standard irrigation solution and delivered to patients undergoing ureteroscopy for removal of ureteral or renal stones. The pharmacokinetic data from this clinical trial show that systemic plasma levels of the APIs of OMS201 in patients were minimal or below the level of quantification. There were no serious adverse events.

Based on the successfully completed Phase 1 trial of a lower concentration of OMS201, we conducted a Phase 1/Phase 2 study designed to evaluate the safety and systemic absorption of two sequentially higher concentrations of OMS201 added to standard irrigation solution and delivered to patients undergoing ureteroscopy for removal of ureteral or renal stones. OMS201 was safe and well tolerated in this study. The incidence of adverse events was similar in the two OMS201-concentration arms and the group receiving vehicle. No adverse events were considered treatment-related by investigators. There were no deaths or discontinuations for adverse events. Only one serious adverse event was reported, which occurred in a vehicle-treated patient.