Thursday, August 1, 2013

Par Pharma initiates Phase 3 study to compare safety and efficacy of its generic version to already marketed formulation of Ciprodex (Alcon)


The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa. The study will enroll 500 patients and expected to complete in July 2014.


The patent protecting Ciprodex expires in August 2020.  Otitis Externa (swimmer’s ear) is an inflammation of the external ear canal that causes pain and may lead to hearing loss. 

According to The American Academy of Otolaryngology (AAO), the annual U.S. incidence rate is 1 per 100 to 250 people or approximately 1.7M people annually which generate approximately 5M office visits. Alcon currently sells the antibiotic Ciprodex (ciprofloxacin/dexamethasone) for Otitis Externa which was licensed from Bayer Healthcare AG. The global human ear medication market is  estimated at $1 Billion of which the US market represents >$400 Million. Most of the revenues were from ear drops containing a combination of antibiotics and steroids (76%) . Alcon leads the US market with two ethical products: Ciprodex and  Cipro HC sold each at $126/unit. The combined revenues from these two products were $275 Million in 2009.



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