Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) approved Vantrela 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 vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.
"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.
Limitation of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Vantrela ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Vantrela ER is not indicated as an as-needed (prn) analgesic. Vantrela ER contains hydrocodone, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.
Important Safety Information
Vantrela ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Vantrela ER and monitor all patients regularly for the development of these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur with the use of Vantrela ER. Monitor for respiratory depression, especially during initiation of Vantrela ER or following a dose increase. Instruct patients to swallow Vantrela ER tablets whole; crushing, chewing or dissolving Vantrela ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone.
Accidental ingestion of even one dose of Vantrela ER, especially by children, can result in a fatal overdose of hydrocodone.
Prolonged use of Vantrela ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols develope...
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