Orexo moves forward with development of rival Suboxone product
Orexo has completed a comparative bioavailability study for its product OX219, a formulation of buprenorphine, with naloxone added to prevent abuse.
The study, which met the expectations of the key pharmacokinetic parameters, was completed on 30th June and is the final study required by the FDA. In the study, OX219 was tested against Reckitt Benckiser's Suboxone (buprenorphine+naloxone sublingual film) and demonstrated both comparative bioavailability for the two active ingredients as well as positive results for product attributes which are important from the patient's perspective.
According to Orexo, the data has met expectations and documents the required equivalence in the key critical pharmacokinetic parameters. The study also provided further insight into important product attributes of the OX219 formulation, which employs Orexo's sublingual technology. The median dissolve time of OX219 in the mouth was more than twice as fast than that of the marketed comparator tablet; the taste was rated better and the overall evaluation including mouth feel yielded a clear preference for OX219.
During third quarter 2012, Orexo will meet with the FDA to discuss its planned submission of an MAA. The programme also awaits completion of product stability tests from the US manufacturing site.