The Food and Drug Administration (FDA) has approved Seglentis® (celecoxib and tramadol hydrochloride) for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Seglentis is a co-crystal formulation of celecoxib, a nonsteroidal anti-inflammatory drug, and tramadol hydrochloride, an opioid agonist and inhibitor of norepinephrine and serotonin reuptake, in a 1:1 molecular ratio.

The approval was based on data from a randomized, double-blind, parallel-group phase 3 trial (ClinicalTrials.gov Identifier: NCT03108482), which evaluated the efficacy and safety of Seglentis in 637 patients 18 years of age and older with acute postoperative pain after unilateral first metatarsal osteotomy with internal fixation. Patients were randomly assigned 2:2:2:1 to receive 2 tablets of Seglentis (56mg/44mg) every 12 hours, tramadol 50mg every 6 hours, celecoxib 100mg every 12 hours, or placebo.

Patients were allowed to use rescue medication (acetaminophen and oxycodone hydrochloride) during the study. Time-weighted summed pain intensity difference over 48 hours (SPID48) was designated as the primary endpoint of the study.


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Results showed that patients in the Seglentis treatment arm had statistically significantly better mean SPID48 scores compared with patients in other treatment arms after bunionectomy. The most common adverse reactions reported with Seglentis included nausea, vomiting, dizziness, headache, and somnolence. 

As it contains tramadol, Seglentis is classified as a Schedule IV controlled substance. “To support the responsible commercialization of Seglentis and as part of our commitment to patients and health care providers, Kowa is implementing multiple measures, including a risk evaluation and mitigation strategy (REMS), to encourage safe and appropriate use of Seglentis,” said  Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America.

Seglentis is supplied as a coated tablet containing 56mg of celecoxib and 44mg of tramadol hydrochloride in 30- and 90-count bottles. The product is expected to be available in early 2022.

References

  1. Esteve Pharmaceuticals receives FDA approval for Seglentis® (celecoxib and tramadol hydrochloride). News release. Kowa Pharmaceuticals America, Inc. October 18, 2021. Accessed October 19, 2021. https://www.kowapharma.com/newsroom/pr-2021-10-18/
  2. Seglentis. Package insert. Kowa Pharmaceuticals America, Inc.; 2021. Accessed October 19, 2021. https://www.kowapharma.com/documents/SEGLENTIS_Prescribing_Information.pdf.