FDA approves combination pill for severe acute pain in adults
The US Food and Drug Administration (FDA) has approved Seglentis a combination of celecoxib and tramadol hydrochloride for severe acute pain in adults, especially when alternative treatments fail to provide adequate pain relief
It is an innovative first-in-class product comprised of a co-crystal form of celecoxib an anti-inflammatory drug and tramadol ,an analgesic for the treatment of acute pain in adults.
The Food and drug administration will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis , as the combination carries the risks of addiction, abuse, and misuse with opioids, even at recommended doses.
The drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals. Further the patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
It is suggested that the prescribing doctors should make the patients aware of naloxone (Narcan) and consider prescribing the opioid antagonist naloxone based on the patient's risk factors for overdose.