Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology

Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology

JERUSALEM–(BUSINESS WIRE)–Jan. 19, 2017– Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved VANTRELATM ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva’s proprietary abuse deterrence technology. VANTRELA ER 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. The product’s approval is supported by a clinical program that evaluated the safety and efficacy of VANTRELA ER, as well as its abuse potential in laboratory-based in itro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.

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“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”

The VANTRELA ER prescribing information (PI) describes the product’s abuse-deterrent properties that are expected to reduce, but not totally prevent, oral, intranasal and intravenous abuse of the drug when the tablets are manipulated. As an opioid, VANTRELA ER is associated with serious risks and the PI contains a Boxed Warning that includes addiction, abuse, and misuse, which can lead to overdose and death, as well as serious, life-threatening, or fatal respiratory depression. Additional boxed warnings and other important safety information can be found below and in the prescribing information.

Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva said, “While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward. We are committed to furthering responsible pain management.”

Adverse reactions in ≥2% of patients in placebo-controlled trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.

ABOUT VANTRELA ER

VANTRELA™ ER (hydrocodone bitartrate) extended-release tablets [CII] is an opioid agonist 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.

http://www.tevapharm.com/

January 20, 2017 / Pharma News