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|Pernix Therapeutics Announces the Issuance of New Orange Book Patent for Zohydro® ER With BeadTek™ CII|
The ‘760 patent, solely owned by
“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
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.
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
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