FDA approves extended-release opioid painkiller
The U.S. Food and Drug Administration gave market clearance to an extended-release opioid painkiller yesterday. It is designed for those with severe pain.
The hydrocodone drug, called Hysingla ER, is supposed to be harder to abuse than other opioids. It is difficult to crush or dissolve the tablet; it forms a thick gel that is hard to inject, FDA officials said.
The medication is likely to be an option for long-term care residents in severe pain. Its safety was evaluated in a trial of 905 people with chronic low back pain. Common side effects include constipation, fatigue, dizziness, headache and upper respiratory tract infection.
Hysingla ER is manufactured by Purdue Pharma L.P.