FDA Approves Oral Solution for Severe Pain Management


The new drug allows for flexible dosing so as to address individual patient needs.


The US Food and Drug Administration (FDA) has approved tramadol hydrochloride (QDOLO Oral Solution) for the management of severe pain in adults.

The approval, granted to Athena Bioscience, is indicated specifically for patients who have not tolerated, or are not expected to tolerate, alternative treatment options. The opioid agonist is also limited to those for whom alternative treatments have not provided adequate analgesia.

The indication comes with a caution for patients to use a calibrated oral syringe or other dosing devices with metric measurements so as to ensure proper dosing amounts provided by a physician. 

Although the oral solution allows flexible dosing for each individual, it nonetheless warns against exceeding 400 mg (80 mL) per day.

The drug should not be used by individuals with acute or severe bronchial asthma while unmonitored; those with known or suspected gastrointestinal obstruction; hypersensitivity to tramadol; or concurrent use of monoamine oxidase inhibitors or use within the past 14 days.

The most common adverse reactions that were reported (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus.

"As an oral liquid, QDOLO gives physicians flexibility to titrate dosing precisely according to individual patients' needs," said Jeff Bryant, President and CEO of Athena Bioscience, in a statement. "In addition, for patients with swallowing disfunction (dysphagia) or who simply have trouble swallowing pills, QDOLO provides an essential alternative to other forms of tramadol."

Last year, the US Department of Health and Human Services report on pain management best practices emphasized the need for an "individualized, patient-centered" approach for the treatment of pain.

Currently, about 19.6 million adults are experiencing high-impact chronic pain that interferes with their daily life or work.

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