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IRX211 is a novel drug-device combination product consisting of a fixed dose of dronabinol (delta-9-tetrahydrocannabinol) delivered via a pressurized metered-dose inhaler (pMDI). Developed by InhaleRx, it is designed to provide rapid onset of action for the treatment of complex regional pain syndrome (CRPS) and potentially panic disorder. By utilizing the inhalation route, IRX211 aims to bypass first-pass metabolism and offer a more predictable pharmacokinetic profile compared to oral cannabinoid formulations. It is currently being evaluated in Phase 1 clinical trials to assess safety and pharmacokinetics in healthy volunteers, following the FDA's 505(b)(2) regulatory pathway.
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