FDA provides guidance on Novus Therapeutics’ development path for OP-02 to treat otitis media

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Novus Therapeutics, Inc., a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), announced receipt of final meeting minutes from the U.S. Food and Drug Administration (FDA) following a Type C meeting held at the Company's request to discuss its OP-02 development program in otitis media.

"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," said Dr. Catherine C. Turkel, President of Novus Therapeutics, Inc.

"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," concluded Dr. Turkel.


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