FDA to review effectiveness of abuse deterrent opioid drugs
pharmafile | June 14, 2017 | News story | Research and Development, Sales and Marketing | FDA, Scott Gottlieb, opioid, opioid crisis
FDA Commissioner Scott Gottlieb continues his fightback against the US opioid crisis after requesting an unprecedented recall of Endo Pharmaceuticals’ painkiller Opana ER by calling for a review of all ‘abuse deterrent’ opioid drugs to confirm their efficacy at preventing addiction and abuse.
Abuse deterrent formulas are designed to be more difficult to be used recreationally due to being resistant to crushing or liquefying, making it considerably harder for them to be snorted or injected. Last weekend, the FDA met with unspecified external thought leaders to evaluate whether such formulas do in fact make these drugs more difficult to abuse.
Gottlieb explained: “We are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?”
“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” he added. “Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimise our assessment of abuse deterrent formulations.”
A report released last month by the Institute for Clinical and Economic Review (ICER) suggests that the effectiveness of abuse deterrent formula drugs is average at best, grading them just a C+.
“Without stronger real-world evidence that abuse deterrent formulas reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit,” the report indicated.
Matt Fellows
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