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This investigational intranasal formulation combines 30 mg of ketorolac tromethamine with lidocaine hydrochloride (at concentrations of 4%, 5%, or 6%). Developed by Egalet Ltd, the product is designed for acute pain management. Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that provides systemic analgesia by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. Lidocaine hydrochloride is included as a local anesthetic to mitigate the nasal stinging and discomfort typically associated with intranasal ketorolac administration, thereby improving patient tolerability. A Phase 1 study demonstrated that the addition of lidocaine improved local tolerability and decreased the time to maximum plasma concentration of ketorolac without affecting peak concentration.
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