FDA Approves Seglentis for Acute Pain Management

The FDA has approved celecoxib and tramadol hydrochloride (Seglentis, Esteve Pharmaceuticals) for acute pain management in individuals with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Due to an agreement between Esteve Pharmaceuticals and Kowa Pharmaceuticals America (Kowa), Kowa will be responsible for the commercialization of celecoxib and tramadol hydrochloride in the United States. Currently, Kowa plans to launch the drug commercialization in early 2022.

“To support the responsible commercialization of Seglentis and as part of our commitment to patients and healthcare providers, Kowa is implementing multiple measures, including a risk evaluation and mitigation strategy (REMS), to encourage safe and appropriate use of Seglentis,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in the statement.

Celecoxib and tramadol hydrochloride is an oral prescription with a unique co-crystal formulation of the anti-inflammatory drug celecoxib and the schedule IV opioid analgesic drug tramadol.

During clinical trials, investigators observed that the most common adverse effects in patients were nausea, vomiting, dizziness, headache, and somnolence.

Celecoxib and tramadol hydrochloride, because of the risk of addiction and abuse, should be used in individuals for whom alternative treatment options are not tolerable or are not expected to be tolerable.

Reference

Esteve Pharmaceuticals Receives FDA Approval for Seglentis (celecoxib and tramadol hydrochloride). Kowa Pharmaceuticals America, Inc. News release. October 18, 2021. Accessed on October 21, 2021. https://www.kowapharma.com/newsroom/pr-2021-10-18/