MORRISTOWN, N.J.--(BUSINESS WIRE)--Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced the successful completion of a human pharmacokinetic equivalence study with 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 INTELLITABTM technology, for comparison with Zohydro® ER, resulting in the selection of the final ZX007 prototype for pivotal clinical studies. Damon Smith, CEO of Altus Formulation said; “We are very happy that ZX007 is performing in the way we expected in human studies and we look forward to working with the Pernix team to complete development”.
Study results 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. Doug Drysdale, President, Chairman and CEO of Pernix said, “We are pleased to have identified the right formulation to move forward into clinical trials, to bring the clinical benefits of ZX007 to patients suffering with chronic pain. Pernix 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. ”
The Zohydro ER NDA and related investigational new drug applications were transferred from Zogenix to Pernix immediately upon closing on April 24, 2015 and Pernix has assumed regulatory and financial responsibility for the ongoing efforts related the development of ZX007, with Zogenix providing assistance in the clinical development of the program under a Transitional Services Agreement for up to 18 months.
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its two Pernix sales forces and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. To learn more about Pernix Therapeutics, visit www.pernixtx.com.
About Altus Formulation
Altus Formulation is a drug formulation and development company using its proprietary and patent protected drug delivery technologies to generate novel, differentiated and cost effective new products for its clients. Altus technologies include the INTELLITABTM abuse resistant platform, FLEXITABTM breakable controlled release tablets and PNDSTM micellar technology for increased bioavailability of small and large molecule drugs.
Zohydro® is a registered trademark of Pernix International.