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Mixed Results in Phase III Trial of Pain Drug for Knee Surgery
No effect on symptoms endpoint, but postoperative pain reduced (Dec. 27)
Mixed results have been reported from a phase III study of the investigational pain drug OMS103HP (Omeros Corporation) in patients undergoing arthroscopic partial meniscectomy surgery.
The double-blind clinical trial compared OMS103HP with vehicle control in 344 patients. The primary endpoint was the symptoms subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) — a patient-reported measure that consists of questions about knee swelling, clicking, catching, and stiffness. In addition, pain measured in the early postoperative period was a secondary endpoint.
Although the symptoms subscale of the KOOS did not reach statistical significance, treatment with OMS103HP significantly reduced postoperative pain versus vehicle control (P = 0.0003). OMS103HP also improved a series of pain-related assessments, including postoperative narcotic use (twice as many OMS103HP-treated subjects required no postoperative narcotics), the incidence of inflammatory adverse events, tourniquet use, and crutch use, as well as the time to discontinuation of crutches and return to work.
OMS103HP is designed to reduce pain and inflammation following arthroscopic surgery by blocking the inflammatory cascade induced by arthroscopy. The drug is a combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs) without anesthetic agents, such as lidocaine or bupivacaine. The APIs in OMS103HP are components of generic, FDA-approved drugs that have been marketed in the U.S. as over-the-counter or prescription drug products for more than 15 years. OMS103HP is delivered directly to the joint in the arthroscopic irrigation solution.
Source: Omeros Corporation; December 27, 2012.