Pernix Releases Positive in vitro Abuse Deterrent Data for Third Generation Extended Release Hydrocodone ZX007

Loading...
Loading...
Pernix Therapeutics Holdings, Inc.
PTX
, a specialty pharmaceutical company, today announced positive results from Category 1 (in vitro) abuse deterrence studies with ZX007, utilizing Altus Formulation's proprietary INTELLITABTM abuse deterrent technology platform. ZX007 is an abuse-deterrent, extended-release oral hydrocodone bitartrate formulation product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The purpose of the studies was to perform a comprehensive battery of laboratory tests to assess the physical and chemical properties of ZX007. These studies were conducted in accordance with the April 2015 Food and Drug Administration (FDA) Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. Top-line results from the study demonstrated ZX007's ability to: Resist common methods of physical manipulation including crushing between spoons, crushing in a tablet hardness tester, and crushing in pill crushers; Resist alcohol induced dose dumping and prevent drug extraction in a range of common solvents; Not yield extracts that could be expelled through syringe needles; and Maintain controlled release after crushing and grinding of the tablets under a number of test conditions. Doug Drysdale, President, Chairman and CEO of Pernix, said, "Pernix is committed to introducing abuse-deterrent formulations of hydrocodone for the benefit of patients who would otherwise have to endure severe pain. We are pleased that this new formulation shows such promising Category 1 results supporting the robust abuse-deterrent properties of ZX007. We look forward to the results of our clinical human abuse liability studies for ZX007 to further expound upon its abuse-deterrent features. Our aim is to bring this new treatment option to the market to reduce the overall burden of opioid misuse and abuse, while providing relief to patients suffering with severe pain." Damon Smith, CEO of Altus Formulation, said; "We are very happy that ZX007 has again met our expectations in these key studies." Results from this study will be submitted for presentation at an upcoming scientific conference later this year.
Loading...
Loading...
Market News and Data brought to you by Benzinga APIs
Posted In: NewsPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...