The U.S. Food and Drug Administration on Thursday approved a new hydrocodone tablet that’s designed to help prevent abuse.
The FDA said that the newly approved Hysingla ER (hydrocodone bitartrate) is an extended-release tablet to treat pain severe enough to require daily, round-the-clock, long-term opioid treatment that can’t be eased by other pain medications.
The drug is not approved for “as-needed” pain relief, the agency said.
This approval “will better enable the agency to balance addressing this problem (of painkiller abuse) with ensuring that patients have access to appropriate treatments for pain,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
According to the FDA, the tablet is difficult to crush, break or dissolve, making it tougher for abusers to snort or inject it.
Dr. Robbins adds that only a small percentage of people abuse it in these ways.
philly.com
11/21/14