FDA Approves New Abuse-Deterrent ER Hydrocodone Tablet
The FDA has approved a new formulation of abuse-deterrent extended-release hydrocodone called Vantrela ER (hydrocodone bitartrate). Developed by Teva, the medication is suggested for management of severe pain that requires all-day, long-term opioid treatment and for which alternative treatment options are inadequate.
Concerned about the rising numbers of opioid-related overdoses, the Food & Drug Administration (FDA) strongly encourages manufacturers of opioid medications to include abuse-deterring properties. The goal of these formulations is to meet the needs of patients who suffer from chronic pain while decreasing the potential to misuse or abuse opioid medications.
In order to receive FDA approval, each manufacturer must submit study data demonstrating that the products are expected to deter, though not entirely prevent, oral, intranasal and intravenous abuse of the drug by crushing the tablet. Vantrela ER is one of nine extended-release opioid formulations with abuse-deterrence technology to receive approval from the FDA.
As mandated by the FDA requirements, Teva used a clinical program to evaluate the safety and efficacy of its new painkiller, as well as its abuse potential. The program involved laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential 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.”
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