COLL - FDA updates safety requirements for opioid pain meds
2023-04-13 16:47:55 ET
- The U.S. Food and Drug Administration (FDA) issued new labeling requirements for opioid pain medications on Thursday, adding warnings about potential drug-induced reactions such as a rise in pain or pain sensitivity.
- Labeling changes include restrictions on the use of immediate -release opioids and extended-release/long-acting opioid analgesics.
- As reasons for its decision, the FDA noted that despite a sharp decline in prescriptions for opioid pain medicines, the patients who continue to use the meds often have leftover tablets that can lead to addiction and overdose.
- The FDA also noted that non-opioid medications and other treatments could relieve pain for multiple chronic pain conditions without the risks of opioid pain medicines.
- Currently, Dsuvia and Nucynta are sold as opioid pain meds by closely-held Alora Pharmaceuticals and Collegium Pharmaceuticals ( NASDAQ: COLL ), respectively. COLL began marketing Nucynta in 2018.
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FDA updates safety requirements for opioid pain meds