FDA: Final guidance on evaluation, labeling of abuse-deterrent opioids

April 1, 2015

FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.

FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.

While drugs with abuse-deterrent properties are not “abuse-proof,” FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.

Related:FDA approves abuse-deterrent labeling for Embeda

“The over-prescribing of opioids, particularly in the worker's comp industry, has helped to accelerate the rate of abuse of this group of pain drugs,” said John Santilli partner, Access Market Intelligence, in Trumbull, Conn.

“The industry has been waiting for some organization to take the lead in combatting this abuse,” Santilli said. “FDA has finally stepped up, prodded by a Congressional amendment that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of FDA Commissioner's office to its criminal investigations department to combat drug diversion. The guidance now puts the onus on the drug manufacturer to begin to develop abuse-deterrent drugs.”

The new guidance explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.

The science of abuse-deterrent technology is still evolving. The final guidance is intended to assist drug makers who wish to develop opioid drug products with potentially abuse-deterrent properties. FDA is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, FDA will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.

"Given the continued alarming rise in prevalence of prescription opioid abuse in the US and its enormous societal implications, this new guidance by the FDA provides a modest but important step forward in helping to promote and enhance consistency in the clinical development of more abuse-deterrant products," said David Calabrese, FormularyWatch Clinical Editor. "With recent data demonstrating a rate of fatalities due to opioid overdose at the highest level in the history of our country (over 16,000 deaths in 2013), I am hopeful this represents just the first of many additional steps the FDA will take in helping to mitigate this significant issue."

While this final guidance does not address generic opioid products, the agency understands the importance of available generic options to ensure appropriate access to effective opioid drugs for patients who need them. The FDA is committed to supporting the development and use of generic drugs that have abuse-deterrent properties and is working on draft guidance in this area.

Related: The rising cost of generic drugs

In addition to the numerous comments on the draft guidance submitted to the public docket, FDA convened a public meeting in Oct. 30-31, 2014, to discuss the development, assessment and regulation of abuse-deterrent formulations of opioid medications.

Read next: New guidelines on generic opioids, biosimilars labeling coming from FDA