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Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway

Novus Therapeutics said that it has initiated a Phase 1 clinical trial of OP0201, an intranasal surfactant that the company is developing for the treatment of otitis media. The 2-week study will evaluate daily administration of 30 mg and 60 mg doses of OP0201, delivered intranasally via MDI, in 30 healthy adults.

Earlier this year, the company announced that it had received guidance from the FDA regarding development plans for the intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension.

Novus Therapeutics President Catherine Turkel, commented, “The initiation of this Phase 1 study represents a significant milestone for the company. Completion of this safety study will position us to quickly move forward and evaluate OP0201 in children with otitis media. Otitis media affects millions of people around the world, particularly young children, and can become extremely burdensome to patients and their caregivers. Given the lack of any approved pharmaceutical treatment options, OP0201 has the potential to be a transformational, first-in-class treatment option that addresses the underlying cause of otitis media.”

Read the Novus Therapeutics press release.

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published on November 27, 2018

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