Pernix Therapeutics Holdings, Inc. has announced the successful completion of a human pharmacokinetic equivalence study of ZX007, an innovative abuse deterrent tablet formulation of hydrocodone bitartrate. The clinical study evaluated the pharmacokinetics and safety of prototype formulations developed by Altus Formulation using its proprietary INTELLITAB™ technology, for comparison with Zohydro® ER, resulting in the selection of the final ZX007 prototype for pivotal clinical studies.
Results from the study demonstrated that the selected ZX007 formulation is pharmacokinetically equivalent with currently marketed Zohydro ER with BeadTek and that it has a consistent safety profile. Selection of the formulation enables the start of pivotal clinical studies later this year, paving the way for the NDA submission for ZX007 in mid-2016. The Zohydro ER NDA and related investigational new drug applications were transferred from Zogenix to Pernix on April 24, 2015. Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the US market. The Company targets therapeutic areas such as CNS, including neurology and pain management. Remarking on the study announcement, Pernix President, Chairman and CEO Doug Drysdale said that the company “…remains committed to supporting the appropriate use of opioids, which includes following best practices for physicians and their patients living with chronic pain, as well as making abuse-deterrent products available. ” Read a press release from Pernix on the study results here.