The FDA has given the nod to an extended-release, abuse-deterrent opioid that’s approved for the management of severe pain for which alternative treatment options are inadequate. Called Vantrela ER, the hydrocodone bitartrate will be made available as 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strength dosages according to its manufacturer, Teva Pharmaceuticals, Inc.
Vantrela ER’s approval comes on the heels of clinical studies that evaluated the safety and efficacy of the drug, 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 in a news announcement. “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 company describes the drug’s abuse-deterrent properties as being expected to reduce, but not totally prevent, oral, intranasal and intravenous abuse of the drug when the tablets are manipulated. As an opioid, the drug carries serious risks, such that the prescribing information a Boxed Warning, which the FDA now requires for opioid analgesics.
“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,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva.
According to the company, the clinical trial showed that adverse reactions occurred in ≥2% of patients in placebo-controlled trials include nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety.
The full prescribing information, including the Boxed Warning and medication guide for Vantrela ER is available here.