New FDA-Approved Ketorolac Formulation

In May 2010, the FDA approved Sprix® Nasal Spray, an intranasal formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID). Sprix® NS is indicated for the short-term management of moderate to moderately-severe pain requiring opioid analgesics, and is reserved for use in the outpatient setting. Currently, ketorolac is available in other formulations, including intramuscular (IM) injections, intravenous (IV) injections, eye drops, and oral tablets. Similar to the ketorolac tablets (Toradol®), the recommended total duration of use should be for the shortest period of time and not to exceed 5 days. This new intranasal formulation will allow for faster absorption and onset of action of the medication (similar to the IM formulation); however, delivering the spray will be much less invasive. Combining this agent with opioid therapy may reduce use of opioids, thereby minimizing side effects and abuse potential. Observed side effects of the intranasal ketorolac are limited to mild, temporary nasal discomfort.  However, intranasal ketorolac has many contraindications. For instance, it is contraindicated in patients with peptic ulcer disease, history of gastrointestinal or cerebrovascular bleeding, or high risk of bleeding in general, as well as in patients with kidney disease, hypersensitivities or allergies to aspirin, ketorolac or other NSAIDs. Sprix® Nasal Spray is not yet currently available.  PMI’s clinical team will provide an update when this new product is on pharmacy shelves.