Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its development plans.
The company explains that OP-2, which is delivered via a metered dose inhaler, “is intended to be used to restore the normal physiologic activity of the Eustachian tube (ET). Together DPPC and CP effectively absorb to the air-liquid interface of the mucosa and reduce the interfacial surface tension of the ET, which reduces passive pressure required for the ET to open. In other words, OP-02 promotes ‘de-sticking’ of the ET so that ventilation and drainage of the middle ear may occur.”
Novus Therapeutics President Catherine C. Turkel commented, “The FDA provided guidance on our planned 505(b)(2) development path for OP-02 and confirmed that no additional preclinical or clinical studies beyond our planned Phase 1 safety study in healthy adults will be required before initiation of Phase 2 studies in children 6-months of age or older with otitis media. In addition, the FDA confirmed that development of OP-02 for separate otitis media treatment and prevention indications is acceptable and provided us with initial guidance on study design for these indications. We look forward to working with the FDA as we continue to develop OP-02 as a potential first-in-class treatment option for the millions of patients burdened by otitis media.”
In 2017, Israeli company Otic Pharma, which was developing OP-02, completed a merger with Tokai Pharmaceuticals, and the resulting company was renamed Novus Therapeutics. Otic CEO Gregory Flesher, who was previously Senior VP of Corporate Development and Chief Business Officer at Avanir Pharmaceuticals, is now CEO of Novus.
Read the Novus Therapeutics press release.
