FDA Approves New Abuse-Deterrent Opioid, Vantrela ER

FDA Approves New Abuse-Deterrent Opioid, Vantrela ER

The FDA has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Vantrela ER is formulated with physiochemical properties intended to make the tablet more difficult to manipulate for misuse and abuse through oral, intranasal, and intravenous routes of administration. This abuse-deterrent technology is expected to reduce, but not totally prevent, abuse and misuse of Vantrela ER.

As with any opioid, Vantrela ER comes with potential risks such as addiction, abuse and misuse, even when used at recommended doses, and these risks can lead to overdose, respiratory depression and death. Extended-release opioids such as Vantrela ER come with an even greater risk of these adverse events, and should only be used for patients where alternative treatment options are ineffective.

For further information, read Teva’s press release, as well as the approved drug label.