The FDA has approved Sprix (ketorolac tromethamine nasal spray, from Roxro Pharma) for the short-term (up to 5 days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level. This approval was based on data from 14 clinical trials involving more than 1,000 patients. Sprix has been tested in four controlled efficacy studies, and met the primary efficacy endpoints in each trial. Phase 3 studies of adults who underwent elective abdominal or orthopedic surgery (n=300 and n=321) indicated that Sprix provided a statistically significant greater reduction in the summed pain intensity difference over 48 hours as compared to those using placebo. Sprix has also demonstrated a 26–36% reduction in morphine use by patients over a 48-hour period as compared with placebo.
Sprix is a prescription intranasal formulation of ketorolac, a non-steroidal anti-inflammatory drug (NSAID).