Pernix Therapeutics Announces the Issuance of New Orange Book Patent for Zohydro® ER With BeadTek™ CII

MORRISTOWN, N.J., Feb. 23, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. PTX, a specialty pharmaceutical company, today announced that the United States Patent and Trademark Office has issued U.S. Patent Number 9,265,760 (the ‘760 patent), covering important safety information related to dosing patients with Zohydro ER with BeadTek. The ‘760 patent is broadly directed to a method of dosing patients with hepatic impairment with hydrocodone where no adjustment in start dose is needed for patients with mild or moderate hepatic impairment.  

The ‘760 patent, solely owned by Pernix, will be a significant addition to the Orange Book, bringing the total of Orange Book listed patents covering Zohydro ER with BeadTek to four. The ‘760 patent will expire July 25, 2033 and will be the second patent to be listed in the last six months as covering Zohydro® ER with BeadTek in the United States Food and Drug Administration's (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

"The critically important safety information protected by the ‘760 patent can be found in the Zohydro ER label, and this patent is expected to provide a significant barrier for generic entry. We continue to invest in the Zohydro ER franchise and currently own or license over a half dozen pending patent applications relating to Zohydro ER with BeadTek." said Doug Drysdale, Chairman and CEO of Pernix Therapeutics.

Zohydro ER with BeadTek is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure to acetaminophen. As covered by the ‘760 patent, no adjustment in starting dose for Zohydro ER is required for patients with mild or moderate hepatic impairment. Zohydro ER with BeadTek is available in strengths 10mg, 15 mg, 20mg, 30 mg, 40mg, and 50mg.

About Zohydro ER with BeadTek

Zohydro ER with BeadTek is an extended-release form of hydrocodone indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER with BeadTek does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. The active ingredient, hydrocodone, is the most commonly prescribed opioid in the U.S., with over 90 million prescriptions in 2015. Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents.

For more information on Zohydro ER with BeadTek including important safety information and the full prescribing information, visit www.zohydroer.com.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of our clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefore; our ability to obtain regulatory approval of our product candidates; our ability to have third parties manufacture our products; competitive factors; our ability to find and hire qualified sales professionals; general market conditions; and other risk factors described in Pernix Therapeutics' filings with the United States Securities and Exchange Commission. Pernix assumes no obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.

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.