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IBU-NAC is a fixed-dose combination (FDC) small molecule drug developed by E Pharma Trento S.p.A. It contains ibuprofen sodium dihydrate (400 mg), a non-steroidal anti-inflammatory drug (NSAID), and acetylcysteine (200 mg), a mucolytic agent. Ibuprofen acts by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), thereby reducing the production of prostaglandins involved in pain, fever, and inflammation. Acetylcysteine works by breaking disulfide bonds in mucoproteins, reducing mucus viscosity and facilitating its clearance from the airways. The combination is primarily investigated for the symptomatic relief of uncomplicated upper respiratory tract infections (URTIs) accompanied by a wet cough in adults. The drug is formulated as granules for oral solution and has been evaluated in the Phase 3 COMBO clinical trial to compare its efficacy and safety against ibuprofen and acetylcysteine monotherapies.
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