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**PL1200 Ibuprofen 200 mg** is a GI-safer, lipid-based formulation of ibuprofen developed by PLx Pharma using the proprietary **PLxGuard™ delivery system**, designed for over-the-counter (OTC) use in treating pain and inflammation. This novel oral capsule significantly reduces gastrointestinal (GI) side effects compared to standard ibuprofen while maintaining equivalent analgesic and anti-inflammatory efficacy, as shown in clinical studies including a six-week endoscopy pilot trial in osteoarthritic patients at prescription doses (400 mg and 800 mg). It leverages a liquid-filled capsule technology to protect the stomach lining, positioning it for potential 505(b)(2) NDA pathway approval, with Phase 1-equivalent status in the FDA process.[1]
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