FDA Urges Redesign of Opioids to Deter Abuse
The US FDA urges another step to combat the epidemic of opioid abuse.
HealthDay News — Continuing their push to combat the nation's epidemic of opioid abuse, US officials on Thursday urged generic drug makers to take steps to redesign drugs such as hydrocodone and oxycodone to make them harder to abuse.
US Food and Drug Administration officials said they were encouraging the generic drug industry to develop pain medicines with "abuse-deterrent properties." For instance, this would make it harder to crush a tablet to snort the contents or dissolve a capsule to inject its ingredients.
The FDA is also requiring makers of brand-name opioids with approved abuse-deterrent labeling to conduct long-term studies to see how effective the formulas are in reducing abuse in the real world. The agency said it realizes that these formulas aren't foolproof and more research is needed. But, given the lower cost of generic drugs, encouraging access to such drugs with abuse-deterrent properties is an important step toward reducing opioid abuse while helping to "ensure access to appropriate treatment for patients in pain," the FDA said.
The draft guidance includes recommendations about studies that should be done to prove that a generic drug is no less abuse-deterrent than a brand-name one. The FDA is asking for feedback from the generic drug industry during a 60-day comment period.
FDA takes important step to increase the development of, and access to, abuse-deterrent opioids: Agency issues draft guidance for abuse-deterrent generics. FDA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm. Accessed March 25, 2016.