FDA urges development of opioid analgesic products that deter abuse
In an effort to address the opioid epidemic, the Food and Drug Administration is urging the development of opioid analgesic products that are harder to manipulate and abuse.
Opioids with abuse-deterrent formulations, or ADFs, are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.
“These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate ‘high,’” FDA commissioner Scott Gottlieb said. “But it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose or death.”
The FDA is posting a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. The FDA issued a final guidance last fall to assist industry in their development of generic versions of approved ADF opioids and support advancements in this area.
“We recognize that the science of abuse deterrence is relatively new, and we need to continue to study and confirm the potential role of ADFs in reducing the rate of misuse and abuse via different routes when used in a population,” Gottlieb said. “Both the formulation technologies and the methods for evaluating those technologies are rapidly evolving. We believe that transitioning from the current market, dominated by conventional opioid analgesics, to one where most opioids have abuse-deterrent properties may have the potential to further reduce misuse and abuse."
Gottlieb continued, "While there are several of these products approved, their uptake has been slow among doctors who are treating patients in pain. One of the reasons for their more limited use is because these new formulations are currently only available as brand-name products, which are inherently more expensive than the numerous non-abuse-deterrent opioids that are also available in generic formulations. Many payers do not cover these ADF formulations.”
Opioids with abuse-deterrent formulations, or ADFs, are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.
“These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate ‘high,’” FDA commissioner Scott Gottlieb said. “But it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose or death.”
The FDA is posting a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. The FDA issued a final guidance last fall to assist industry in their development of generic versions of approved ADF opioids and support advancements in this area.
“We recognize that the science of abuse deterrence is relatively new, and we need to continue to study and confirm the potential role of ADFs in reducing the rate of misuse and abuse via different routes when used in a population,” Gottlieb said. “Both the formulation technologies and the methods for evaluating those technologies are rapidly evolving. We believe that transitioning from the current market, dominated by conventional opioid analgesics, to one where most opioids have abuse-deterrent properties may have the potential to further reduce misuse and abuse."
Gottlieb continued, "While there are several of these products approved, their uptake has been slow among doctors who are treating patients in pain. One of the reasons for their more limited use is because these new formulations are currently only available as brand-name products, which are inherently more expensive than the numerous non-abuse-deterrent opioids that are also available in generic formulations. Many payers do not cover these ADF formulations.”