Abuse-Deterrent Generic Opioid Guidance
FDA has published a guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, to assist those planning to develop and submit an ANDA for a generic version of a solid oral opioid drug product that references an opioid drug product with abuse-deterrent properties described in its labeling. The document recommends studies, including comparative in vitro and pharmacokinetic studies, that the potential applicant should conduct and submit to the agency in an ANDA to demonstrate that a generic solid oral opioid drug product is no less abuse deterrent than its reference-listed drug with respect to all potential routes of abuse.
Included in the guidance are an Introduction, Background, Abuse Deterrence of Generic Solid Oral Opioid Drug Products, Routes of Abuse, Comparative In Vitro Studies, Comparative In Vivo Studies, Statistical Analysis, Additional Studies, and five appendices.
In a statement, FDA commissioner Scott Gottlieb says that 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. “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,” he says. “One of the factors that FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.”
According to Gottlieb, the agency is taking additional steps beyond the guidance to help developers of generic abuse-deterrent formulations to navigate the regulatory path to market as quickly as possible and to make the review process more efficient and predictable. For example, he says, FDA is developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both innovator and generic opioid drug products. And it’s taking a “flexible, adaptive approach to the evaluation and labeling of abuse-deterrent opioids.”