The U.S. Food and Drug Administration issued a draft guidance on Thursday to help drugmakers in their development of generic anti-abuse opioids.
The guidance aims to help the industry while ensuring that generic versions of drugs with abuse-deterrent formulations (ADF) are no less abuse-deterrent than the branded ones.
The release of the paper is part of the FDA's mission to reassess its plan on opioid medication management and reverse the opioid epidemic while providing relief to patients suffering from pain.
FDA Commissioner Dr. Robert Califf says that generic opioids can be an "appropriate and affordable option" not only for the millions of citizens suffering from significant pain, but also for the health care systems serving them.
Opioid Abuse And Use Of Abuse-Deterrent Opioids
Abuse is the intentional and non-therapeutic use of substances to attain a desirable physical or psychological effect.
Prescription opioids are vital parts of the entire care plan for pain management. However, abuse and misuse of the drugs have significantly increased, causing opioid abuse to become a widespread public health dilemma. This has prompted the FDA to implement different strategies to solve the problem, including having "black box" warnings on labels of immediate-release opioid drugs.
The FDA also believes that developing drugs that deter abuse is a potentially vital intervention to create safer opioids. In fact, the agency regards this step to be a high public health priority.
In the newly released draft guidance, FDA urges the industry to create drugs that are harder to abuse.
By FDA definition, abuse-deterrent drugs are those that contain properties that can significantly deter abuse, even if it does not completely prevent it.
Technology In Making Abuse-Deterrent Opioids
Califf says the agency acknowledges that the technology involved in making abuse-deterrent drugs is still evolving and that it occupies just a small portion of the entire opioid abuse management strategy.
"But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy," Califf says.
With the relatively lower costs of generic medicines, promoting the development of generic anti-abuse drugs will boost access to proper treatment for patients suffering from pain.
More Studies To Establish The Impacts Of Abuse-Deterrent Opioid Drugs
The FDA has also ordered all branded anti-abuse opioid sponsors to perform long-term studies to see the effectiveness of such drugs in reducing abuse.
Drugmakers submitting a new drug application should also evaluate their proposed generic drug in comparative studies to show that a generic opioid is no less abuse-deterrent that branded ones.
Seeking Help From Outside Experts And The Public
The FDA will hold a public conference toward the end of the year to discuss the draft guidance on generic products with ADF, as well as other issues involved in abuse-deterrent technologies. The agency will consider feedback from this meeting in making the final guidance.
Dr. Douglas Throckmorton, the deputy director at the agency's Center for Drug Evaluation and Research, says collaboration is vital in promoting innovation in the area of abuse deterrence. The agency is looking forward to making discussions about abuse-deterrent technologies in the future, he adds.
All stakeholders are encouraged to provide feedback during the comment period, which will run for 60 days.