May 2010 FDA Approves Intranasal NSAID
Saturday, May 8th, 2010
WASHINGTON — The FDA approved ketorolac tromethamine (Sprix), a short-term use, intranasal painkiller for moderate to moderately severe pain, for use in patients who require an analgesic at the opioid level.
The drug is an inhaled form of a non-narcotic, nonsteroidal anti-inflammatory injectable analgesic for use in ambulatory patients.
Drug approval was based on two phase III, placebo-controlled clinical trials of a combined 621 adult abdominal (n=300) and orthopedic (n=321) surgery patients.
Patients reported a statistically significant reduction in summed pain intensity difference over 48 hours following surgery in ketorolac tromethamine over placebo. The study also found patients required 26% to 36% less morphine than those prescribed placebo.
Ketorolac tromethamine, as a spray or injectable, should not be used for more than five days in a row.
The drug is contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis, or those with high risks of bleeding. It is also contraindicated in patients with peptic ulcer disease or a history of gastrointestinal bleeding, patients requiring treatment for perioperative pain in coronary artery bypass graft surgery, those with advanced renal impairment, and those at risk for renal failure due to volume depletion.
The nasal spray should not be used with probenecid or pentoxifylline.
Side effects include mild nasal discomfort, new onset or worsening of hypertension, fluid retention, edema, oliguria, elevation of serum urea nitrogen and creatinine, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and rhinalgia.
The drug is manufactured by Roxro Pharma of Menlo Park, Calif