Akorn, Inc. has announced the FDA approval of NDA 22-221 for Akten™ Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. The NDA was filed June 29, 2007 following the results from a randomized, placebo controlled, Phase III clinical trial in 209 subjects who met the primary endpoint in all three dosing arms (p<0.001). Akten™ is the first NDA ocular anesthetic approved by the FDA in four decades, and will be launched in October 2008. Akten™ is a novel, unit dose, preservative free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent. The estimated market size for Akten™ is approximately eleven million procedures annually. The major procedures include cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection. Akorn has filed two United States patents and one International patent on the formulation and method of use of Akten™. Abu Alam, Ph.D., Akorn’s Senior Vice President of New Business Development stated, “The robust data from the multi-center clinical trial with respect to rapid onset and extended duration of anesthesia will be ideally suited for many ophthalmic procedures in both hospital and office based surgical setting. We would like to thank Drs. Elias Reichel and Brandon Busbee, who collaborated with Akorn on the clinical trial design, execution of the protocol and the three patents filed.” Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “This is a very important milestone in our Company’s history, because it represents our first internally developed NDA drug product. We expect Akten™ to become the standard of care whenever an ocular anesthetic is prescribed. Akten™ will be manufactured at our Somerset, NJ facility and will be marketed directly to hospitals and ophthalmologists with a targeted detail sales effort, by our 65 sales representatives.”
