Akorn, Inc. announced the positive results of a phase III pivotal trial for Akten. The clinical trial was a randomized, placebo controlled, multi-centred, 4-arm trial in 209 subjects. The primary efficacy end point for achieving ocular anaesthesia (p less than 0.001) and the secondary end point for duration of anaesthesia (p less than 0.001) were both statistically significant for all three study drug dosages.

Akten is an Investigational New Drug (IND) product indicated for ocular anaesthesia. Akorn filed a patent for Akten in October 2006. The protocol design was discussed with the US FDA prior to filing the IND in 2006. Akorn now intends to file a 505(b)(2) New Drug Application (NDA) in the second quarter of 2007. Akten is intended to be used in various surgical and office-based ophthalmic procedures with an estimated market size of six million annual procedures.

Abu Alam, PhD, Akorn's senior vice president of New Business Development and Clinical Study Director stated, "This is a very important milestone in our company's history. Akten is expected to be the first ethical drug product internally developed by Akorn. Akten is a unit dose, preservative free drug product and is manufactured at our Somerset, New Jersey facility. Once approved, Akten will be marketed directly by Akorn to ophthalmologists".

Arthur S. Przybyl, Akorn's president and chief executive officer stated, "Akten represents an important proprietary ophthalmic drug product opportunity for Akorn. These trial results will allow us to proceed with the NDA filing in the second quarter of 2007".

Akorn, Inc., headquartered in Buffalo Grove, Illinois, develops, manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals.