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OP0201 is a first-in-class, intranasal drug-device combination product developed for the treatment of otitis media (middle ear inflammation). The product consists of a proprietary surfactant formulation—specifically dipalmitoylphosphatidylcholine (DPPC) and cholesteryl palmitate (CP)—delivered as a nasal aerosol. Its mechanism of action involves restoring Eustachian tube function by reducing the surface tension required to open the tube, thereby facilitating the natural drainage of fluid from the middle ear into the nasopharynx. Originally developed by Otic Pharma and later advanced by Novus Therapeutics (now Eledon Pharmaceuticals), OP0201 was designed as a non-antibiotic and non-surgical alternative for patients with acute otitis media and otitis media with effusion. The program reached Phase 2 clinical trials before the developer shifted its strategic focus toward other therapeutic areas.
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