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FDA Approved Vantrela ER (hydrocodone) With Abuse-Deterrent Formula

January 26, 2017
Latest introduction of abuse-deterrent formulations of opioids for chronic pain management.

The Food and Drug Administration (FDA) has approved Vantrel ER (hydrocodone bitartrate extended-release) tablets with a proprietary abuse-deterrence technology aimed at preventing tampering and misuse by the oral, intranasal, and intravenous routes,1 according to a press announcement released by Teva Pharmaceuticals.

For clinicians, the ability to offer much-needed pain relief has become a balancing act between the value of offering their patients effective medications to relieve significant and unrelenting pain and the potential for overuse and abuse of these pain pills.

Vantrela ER, a class II pain reliever with  customized, tamper-proof formulation, received FDA approval for 24-hour pain relief.

In February 2016, Robert Califf, MD, the FDA Commissioner, announced an 8-point action plan to address federal policies in pain management. The goal of the plan is to preserve access to opioids while addressing the issue of misuse and abuse of these medications.2 One of the action steps has been to “expand access to, and encourage the development of, abuse-deterrent formulations of opioid products.”

 “This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis,” Dr. Califf stated in an FDA press release.2  The toll that opioid abuse has taken on families and communities, particularly deaths attributed to opioid overdoses, have required urgent changes.

Pharmaceutical companies, including Teva, have been responding to the FDA with new formulations aimed to deliver pain relief for patients whose need is real, but to deter use by those for whom the medication is not intended.

“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 chief executive officer of Global Specialty Medicines at Teva Pharmaceuticals.  “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.”

Teva has customized CIMA technology to deliver superior abuse-deterrent technology as oral tablets. Their CIMA formulation is based on a multi-layer polymer coating that permits extended drug release, and acts as a deterrent against the main forms of abuse: crushing for snorting, IV extraction, and dose dumping in alcohol.  

“While no technology can completely eliminate abuse, Teva’s proprietary abuse deterrence technology is an important step forward,” said Michael Hayden, MD, PhD, Chief Scientific Officer at Teva. “We are committed to furthering responsible pain management.”

Last updated on: January 26, 2017
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