FDA News

FDA issues guidance on developing generic abuse-deterrent opioids

Photo of Scott Gottlieb
Scott Gottlieb

Today, the FDA revealed its newest action to reduce the span of the opioid abuse and addiction crisis — guidance to assist the development of generic versions of approved opioids formulated to deter abuse.

The FDA plans to decrease unnecessary exposure to opioids by promoting the development of improved alternatives that are harder to manipulate and abuse for patients who need pain medications. It is critical to also encourage the use of opioids with abuse-deterrent formulations over opioids without such properties until a new nonopioid drug for pain management is available, according to Scott Gottlieb, MD, commissioner of the FDA.

“To date, the FDA has approved 10 opioid drugs with [abuse-deterrent] properties,” Gottlieb said in a statement. “But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold.”

Gottlieb noted that some clinicians may not be aware of abuse-deterrent opioids or may not know when to prescribe them. Price is also a significant barrier, as opioids with abuse-deterrent formulations are only available as brand-name drugs which are characteristically more expensive than generics.

“Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit,” Gottlieb said. “But to transition this market more quickly to the [abuse-deterrent formulations], and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe — there are a number of factors we must consider.”

Generic competitors must be introduced to the market to allow for improved access to newer abuse-deterrent formulations for appropriate patients, according to Gottlieb.

In the new guidance, the FDA recommends that companies conduct studies to validate that current generic drugs are no less abuse-deterrent than their brand-name counterparts.

The FDA is also making strides to enhance testing methodologies for assessing abuse deterrence, help developers of generic opioids with abuse-deterrent formulations quickly navigate the regulatory path to the market and advance the review process, according to Gottlieb. Moreover, evaluating and labeling abuse-deterrent opioids will be more flexible, he said.

The guidance will help arrange meetings between the FDA and the generic drug developers to help smooth out scientific and regulatory issues prior to the submission of applications to allow for clarification of expectations and a reduction in the duration of approval.

“Together, all of these efforts are aimed at creating a more robust path for applicants who plan to develop and seek approval of generic [abuse-deterrent] opioids,” Gottlieb said. “Our goal is, when the use of any opioid drug product is appropriate, to make prescribing of these new formulations more commonplace.”

“But let us be clear on one point,” he added. “While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose or death.”

For more information:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.

 

Photo of Scott Gottlieb
Scott Gottlieb

Today, the FDA revealed its newest action to reduce the span of the opioid abuse and addiction crisis — guidance to assist the development of generic versions of approved opioids formulated to deter abuse.

The FDA plans to decrease unnecessary exposure to opioids by promoting the development of improved alternatives that are harder to manipulate and abuse for patients who need pain medications. It is critical to also encourage the use of opioids with abuse-deterrent formulations over opioids without such properties until a new nonopioid drug for pain management is available, according to Scott Gottlieb, MD, commissioner of the FDA.

“To date, the FDA has approved 10 opioid drugs with [abuse-deterrent] properties,” Gottlieb said in a statement. “But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold.”

Gottlieb noted that some clinicians may not be aware of abuse-deterrent opioids or may not know when to prescribe them. Price is also a significant barrier, as opioids with abuse-deterrent formulations are only available as brand-name drugs which are characteristically more expensive than generics.

“Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit,” Gottlieb said. “But to transition this market more quickly to the [abuse-deterrent formulations], and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe — there are a number of factors we must consider.”

Generic competitors must be introduced to the market to allow for improved access to newer abuse-deterrent formulations for appropriate patients, according to Gottlieb.

In the new guidance, the FDA recommends that companies conduct studies to validate that current generic drugs are no less abuse-deterrent than their brand-name counterparts.

The FDA is also making strides to enhance testing methodologies for assessing abuse deterrence, help developers of generic opioids with abuse-deterrent formulations quickly navigate the regulatory path to the market and advance the review process, according to Gottlieb. Moreover, evaluating and labeling abuse-deterrent opioids will be more flexible, he said.

The guidance will help arrange meetings between the FDA and the generic drug developers to help smooth out scientific and regulatory issues prior to the submission of applications to allow for clarification of expectations and a reduction in the duration of approval.

PAGE BREAK

“Together, all of these efforts are aimed at creating a more robust path for applicants who plan to develop and seek approval of generic [abuse-deterrent] opioids,” Gottlieb said. “Our goal is, when the use of any opioid drug product is appropriate, to make prescribing of these new formulations more commonplace.”

“But let us be clear on one point,” he added. “While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose or death.”

For more information:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf

Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.

 

    See more from Opioid Resource Center