FDA OKs Tramadol Hydrochloride Oral Liquid for Pain Management

Officials with the FDA approved tramadol hydrochloride (Qdolo; Athena Bioscience) oral solution 5 mg/1 mmL C-IV for the management of severe pain in adults, according to a press release.

Tramadol hydrochloride oral solution, an opioid antagonist, is indicated for use when pain is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Because of its oral liquid form, the product offers flexibility to titrate dosing precisely according to individual patients’ needs, and accommodates patients with dysphagia or who have difficulty swallowing pills, according to Jeff Bryant, President and CEO of Athena Bioscience.

Tramadol hydrochloride use with agonist/antagonist and partial agonist opioid analgesics should be avoided as it may reduce analgesic effect or precipitate withdrawal symptoms, according to the prescribing information.

To avoid dosing errors due to confusion between mg and mL, ensure accuracy when prescribing, dispensing, and administering tramadol hydrochloride, according to Athena. Patients should be educated on how to measure and take the correct dose and to use extreme caution when measuring the dose. Patients should also be advised to always use a calibrated oral syringe or other oral dosing device, with metric units of measurements to correctly measure. Patients should be informed that they may obtain oral dosing devices from the pharmacy.

Additionally, tramadol hydrochloride oral solution should not be used concomitantly with other tramadol-containing products. When initiating the dosing regimen for each patient, the patient’s severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse should be taken into consideration. Patients should be monitored closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases and adjust dosing accordingly.

The most common adverse events in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus.

The product will be available at chain, independent, and specialty pharmacies. Qdolo currently has a patent pending.

Reference

US FDA Approves Athena Bioscience’s New Drug Application (NDA) for QDOLO (tramadol hydrochloride) Oral Solution. News release. Athena Bioscience; September 8, 2020. Accessed September 9, 2020. https://www.prnewswire.com/news-releases/us-fda-approves-athena-biosciences-new-drug-application-nda-for-qdolo-tramadol-hydrochloride-oral-solution-301125112.html​