Ketorolac is a nonopioid mixed COX1/2 inhibitor used for short-term (up to 5 days) management of moderate-to-severe acute pain. An intranasal (IN) formulation of ketorolac is in development as a self-administered alternative to injectable ketorolac and opioids for pain management. The pharmacokinetics of IN ketorolac are similar to those of ketorolac administered intramuscularly. The efficacy and tolerability of IN ketorolac were assessed in phase 2/3 clinical trials in 705 patients (men and women, ≥18 yr). Abdominal and orthopedic surgery models were used to assess IN ketorolac efficacy in managing moderate-to-severe acute pain. Patients received IN ketorolac (31.5 mg) (n=455) or placebo (n=250) 3 or 4 times a day for up to 5 days. Statistically significantly greater reductions in the summed pain intensity difference over 48 hr occurred in patients receiving IN ketorolac compared to placebo (P<0.05). The most common adverse events in the IN ketorolac group were transient nasal discomfort (15% vs. 2% placebo) and rhinalgia (12% vs <1% placebo). Most patients received concurrent opioid analgesics for the first 48 hr. Morphine use (mg) was calculated by adding all PCA morphine and morphine equivalents (using American Pain Society guidelines for other analgesic medications). Patients in the IN ketorolac group used 34% less morphine over 48 hours after surgery compared to the placebo group (P<0.001). In the first 8 hr after surgery, patients receiving IN ketorolac undergoing orthopedic surgery had greater decreases in opioid use relative to placebo than did abdominal surgery patients. Reductions in opioid use were similar when stratified by age and sex. Efficacy in this clinical model indicates that IN ketorolac provides a noninjection parenteral option for management of acute moderate-to-severe pain that may be particularly useful for ambulatory patients, particularly where avoidance of, or reductions in, opioid use are desirable. (Supported by ROXRO PHARMA). Ketorolac is a nonopioid mixed COX1/2 inhibitor used for short-term (up to 5 days) management of moderate-to-severe acute pain. An intranasal (IN) formulation of ketorolac is in development as a self-administered alternative to injectable ketorolac and opioids for pain management. The pharmacokinetics of IN ketorolac are similar to those of ketorolac administered intramuscularly. The efficacy and tolerability of IN ketorolac were assessed in phase 2/3 clinical trials in 705 patients (men and women, ≥18 yr). Abdominal and orthopedic surgery models were used to assess IN ketorolac efficacy in managing moderate-to-severe acute pain. Patients received IN ketorolac (31.5 mg) (n=455) or placebo (n=250) 3 or 4 times a day for up to 5 days. Statistically significantly greater reductions in the summed pain intensity difference over 48 hr occurred in patients receiving IN ketorolac compared to placebo (P<0.05). The most common adverse events in the IN ketorolac group were transient nasal discomfort (15% vs. 2% placebo) and rhinalgia (12% vs <1% placebo). Most patients received concurrent opioid analgesics for the first 48 hr. Morphine use (mg) was calculated by adding all PCA morphine and morphine equivalents (using American Pain Society guidelines for other analgesic medications). Patients in the IN ketorolac group used 34% less morphine over 48 hours after surgery compared to the placebo group (P<0.001). In the first 8 hr after surgery, patients receiving IN ketorolac undergoing orthopedic surgery had greater decreases in opioid use relative to placebo than did abdominal surgery patients. Reductions in opioid use were similar when stratified by age and sex. Efficacy in this clinical model indicates that IN ketorolac provides a noninjection parenteral option for management of acute moderate-to-severe pain that may be particularly useful for ambulatory patients, particularly where avoidance of, or reductions in, opioid use are desirable. (Supported by ROXRO PHARMA).
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