Companies making opioid painkillers were given a better idea by the U.S. government today of how to prove their pills are resistant to abuse by recreational users.
The Food and Drug Administration proposed a guideline outlining studies drugmakers should conduct to demonstrate abuse deterrence. The guidance also makes clear to companies what claims abuse-resistant painkillers can make on the ability to block the effect of an opioid when manipulated, such as when the pills are crushed and snorted for a more intense effect.
The FDA isn’t requiring abuse-resistant painkillers, rather it wants to determine what strategies work best, Douglas Throckmorton, deputy director at the agency’s office that oversees drug reviews, said on a conference call with reporters. Regulators plan to be flexible as companies adopt the technology.
“This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse,” Commissioner Margaret Hamburg said in a statement, calling opioid addiction a major public health challenge.
FDA advisers decided Dec. 7 against recommending Zogenix Inc. (ZGNX)’s single-ingredient hydrocodone painkiller Zohydro for approval after they determined it needed more protections from abuse. Zogenix is working on an abuse-deterrent formulation that hasn’t been submitted to the FDA for approval.
Endo Health Solutions Inc. (ENDP) already makes an extended- release oxymorphone called Opana that is tamper resistant. The Chadds Ford, Pennsylvania-based company took its earlier version of Opana without the abuse deterrent off the market.
Endo can’t claim the product is abuse-resistant on the label. The FDA hasn’t approved any labeling that claims an opioid can reduce abuse, Throckmorton said.
Purdue Pharma, based in Stamford, Connecticut, is working on an abuse-resistant formulation of pure hydrocodone, the company said last month in a statement.
The FDA is asking for public comment on the guideline for 60 days and plans to hold a public meeting, which hasn’t yet been scheduled.
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