REHOVOT, Israel–(BUSINESS WIRE)–
Otic Pharma, a privately held biopharmaceutical company focused on the development of innovative, localized, aerosol foam-based products for Ear, Nose and Throat (ENT) disorders, announces encouraging feedback from a Pre-IND meeting held recently with the FDA concerning the clinical development plan of its lead investigational new drug product, FoamOtic Externa (0.3% Ciprofloxacin). FoamOtic Externa is a single agent, steroid-free product, which was studied in a Phase 2 clinical trial with 220 minor and adult patients with Acute Otitis Externa (AOE). The Agency agrees that the 505(b)(2) new drug application regulatory pathway is appropriate for the submission of the FoamOtic Externa product. FDA agrees that a single placebo-controlled Phase 3 clinical trial might be potentially adequate, pending review of the total information submitted in the NDA.
About the Pre-IND meeting with the FDA
Otic Pharma is developing FoamOtic Externa (0.3% ciprofloxacin), a novel aerosol foam formulation of ciprofloxacin for ototopical administration in the treatment of AOE.
The purpose of the Pre-IND meeting was to obtain the Agency’s comments and guidance regarding the clinical development program in support of NDA filing.
“We are very pleased with the positive feedback from the Agency with regards to the development plan of FoamOtic Externa. Based on the responses received from the Agency, we will be initiating a U.S.-based Phase 3 clinical trial with FoamOtic Externa during 2015,” said Orna Palgi, Ph.D., executive Vice President of Otic Pharma.
The planned clinical trial is a randomized, multicenter, placebo-controlled, double-blind, Phase 3, enrolling approximately 400 patients, 6 months of age and older. Study endpoints include cure rate, pathogen eradication rate, time-to-end of pain and safety profile of the drug.
About FoamOtic Externa
FoamOtic Externa is an investigational proprietary, foam-based, extended-release formulation of ciprofloxacin antibiotic, which has been designated for self-applied once-daily administration to potentially treat AOE.
The FoamOtic platform attempts to address the inherent limitations of ear drops. For example, the foam should provide good coverage of the infected area; it does not drip out of the ear providing continuous release of the drug.
The primary indication studied for FoamOtic is for the potential treatment of AOE in minor and adult patients.
AOE or “swimmer’s ear” is a generalized inflammation of the epithelium of the external ear canal which may also involve the pinna and/or the tympanic membrane. It is variably characterized by erythema, edema, increased sebum or exudates, and desquamation of the epithelium. AOE is a common, worldwide otologic problem occurring in humans mainly during hot and humid weather. The vast majority of the cases of AOE are due to bacterial infections. The common treatment of AOE consists of topical antibiotics, with or without steroids, analgesia and water avoidance. Otic preparations are generally supplied in the form of ear drops. There are approximately 2.5 million cases of AOE per year in the United States.
About Otic Pharma, Ltd.
Otic Pharma, established in 2008, is a clinical-stage company with a pipeline of products for the treatment of ENT disorders. The products are based on FoamOtic, a proprietary foam-based drug delivery system providing sustained exposure of drugs. Otic Pharma has three additional product candidates in pre-clinical development. FoamOtic Externa completed a Phase 2 clinical trial in minor and adult patients with AOE and is transitioning to initiate a U.S.-based Phase 3 pivotal trial to support a potential NDA submission in 2016.
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Otic Pharma Announces Encouraging Feedback From a Pre-IND Meeting with the Food and Drug Administration (FDA)
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