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This drug is an immediate-release/extended-release (IR/ER) formulation of ibuprofen developed by Pfizer Consumer Healthcare for the treatment of post-operative dental pain. The formulation contains 600 mg of ibuprofen per tablet, consisting of a 200 mg immediate-release component for rapid onset and a 400 mg extended-release component for sustained relief, designed for dosing every 12 hours. As a nonsteroidal anti-inflammatory drug (NSAID), it works by inhibiting cyclooxygenase (COX) enzymes, thereby reducing the synthesis of prostaglandins that mediate pain and inflammation. Pfizer conducted Phase 2 clinical trials (such as NCT00913627) evaluating different manufacturing formulations (roller compaction and wet granulation) of this prototype in patients with moderate to severe pain following third molar extraction, demonstrating rapid onset and sustained analgesia over 12 hours.
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