- The Food and Drug Administration on Tuesday issued final guidance on developing abuse-deterrent opioid generics in an effort to make it easier and faster for manufacturers to bring them to market.
- So far, the agency has approved 10 opioid products with abuse-deterrent properties. Looking to increase that number, the FDA's new guidance outlines how makers of generic opioids can best show their drugs are just as difficult to exploit as the products they reference. One suggestion was to use a tiered system that evaluates a drug's safety profile based on a series of increasingly complex measures a patient would have to go through to abuse it.
- "Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence," FDA Commissioner Scott Gottlieb said in a Nov. 21 statement.
Opioid abuse has ravaged the U.S. healthcare system in recent years, prompting the FDA to take on initiatives aimed at combating the crisis. In 2015, the agency issued guidance about what exactly makes an opioid abuse-deterrent. Now, it's looking to get more drugs that meet those standards on the market and available to patients.
Tucked into the FDA's latest guidance are recommendations on what needs to be included in an abbreviated New Drug Application (ANDA) to demonstrate a solid, oral, generic opioid carries the same abuse-deterrent properties as its reference product, as well as the most efficient ways of obtaining that information.
For instance, the agency advises drugmakers use tier-based and/or performance-based approaches when comparing investigational drugs to their reference products. The former approach is meant to cap the number of tests researchers need to perform by assessing the drug only at various tiers — which are defined by how complex the process would be for a patient to manipulate the product (think crushing or dissolving it). The latter approach is meant to determine how a test product fares across various routes of abuse, which include ingesting, injecting and smoking.
The FDA also recommended that tier-based evaluation should be used when testing a drug in-vivo, and that all ANDAs for generic, abuse-deterrent opioids come with data from extraction studies.
Between 1999 and 2015, at least 183,000 people in the U.S. died from prescription opioid-related overdoses, according to the Centers for Disease Prevention and Control. While abuse-deterrent opioid painkillers offer safer options in many regards, many factors have stifled their uptake.
"The reason for their more limited use is likely multifold," Gottlieb said in the statement. "We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations."
"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," he added.