September 9, 2020

The U.S. FDA has approved Qdolo® (tramadol) 5mg/mL oral solution, manufactured by Athena Biosciences. The drug is indicated to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Tramadol, the active pharmaceutical ingredient of Qdolo, has been FDA approved since 1995. It is used to treat both acute and chronic pain and is considered a Schedule IV controlled substance. Schedule IV drugs are considered to have a relatively low potential for abuse compared to Schedule III drugs. Tylenol with Codeine® is an example of a Schedule III drug.

Recommended dosing for Qdolo is based on severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse. A black box warning cautions that there is a risk of medication errors; addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome P450 isoenzymes; and risks from concomitant use with benzodiazepines and other CNS depressants. Qdolo is only available through a Risk Evaluation and Mitigation Strategy (REMS) program.

Launch and pricing plans are not yet available.

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