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Teva gets FDA’s OK for Vantrela ER

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Opioid painkiller features Teva’s abuse deterrence technology

JERUSALEM, Israel — Teva Pharmaceutical Industries Ltd. has received Food and Drug Administration approval for Vantrela ER, an opioid pain medication with Teva’s abuse deterrence technology.

Vantrela ER (hydrocodone bitartrate extended-release tablets, CII) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which other treatment options are inadequate.

“Teva understands the risk of prescription drug abuse is a challenge health care professionals face when treating millions of Americans affected by chronic pain,” stated Rob Koremans, president and chief executive officer 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.”

Vantrela ER’s abuse-deterrent properties are expected to reduce — but not totally prevent — oral, intranasal and intravenous abuse of the drug when the tablets are manipulated, Teva noted.

“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward,” commented Michael Hayden, president of global R&D and chief scientific officer at Teva. “We are committed to furthering responsible pain management.”


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