General Information

Sprix is an intranasal formulation of Ketorolac, a non-steroidal anti-inflammatory drug.

Sprix is specifically indicated for adults for the short-term (up to five days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Mechanism of Action

Sprix is an intranasal formulation of the non-steroidal anti-inflammatory drug Ketorolac. Ketorolac is an analgesic that inhibits the enzyme cylooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced synthesis of prostaglandins, thromboxanes and prostacyclin.

Side Effects

Adverse events associated with the use of Sprix may include, but are not limited to, the following:

• nasal discomfort
• rhinalgia
• lacrimation increased
• throat irritation
• oliguria
• rash

Dosing/Administration

Sprix is supplied as a solution for intranasal inhalation. The total duration of use of Sprix alone or sequentially with other formulations of ketorolac must not exceed five days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses. The recommended initial dose of Sprix is as follows:
Adults < 65 years of age: 31.5 mg Sprix (one 15.75 mg spray in each nostril) every six to eight hours. The maximum daily dose is 126 mg (four doses).
Reduced doses for special populations: For patients > 65 years of age, renally impaired patients, and adult patients less than 50 kg (110 lbs.), the recommended dose is 15.75 mg Sprix (one 15.75 mg spray in only one nostril) every six to eight hours. The maximum daily dose is 63 mg (four doses).

Clinical Trial Results

The FDA approval of Sprix was based on two multicenter, randomized, double-blind, placebo-controlled studies for post-operative pain.
Study 1
This study enrolled 300 adults who had undergone elective abdominal or orthopedic surgery. The subjects received Sprix or placebo administered every eight hours and morphine administered via patient-controlled analgesia on an as-needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the summed pain intensity difference over 48 hours in patients who received Sprix as compared to those receiving placebo. The patients treated with Sprix required 36 percent less morphine over 48 hours than those treated with placebo.
Study 2
This study enrolled 321 subjects who had undergone elective abdominal surgery. The subjects received Sprix or placebo administered every six hours and morphine administered via patient- controlled analgesia on an as needed basis. Efficacy was demonstrated as a statistically significant greater reduction in the summed pain intensity difference over 48 hours in patients who received Sprix as compared to those receiving placebo. The patients treated with Sprix required 26 percent less morphine over 48 hours than those treated with placebo.