FDA Clears Novel Pain Treatment

Seglentis’ co-crystal formulation targets four complementary pain relief mechanisms.

The FDA approved a first-in-class acute pain treatment. Seglentis, developed by Esteve, is made up of a co-crystal form of the anti-inflammatory celecoxib and the analgesic tramadol.

The multimodal treatment approach targets four complementary pain relief mechanisms and “offers a new treatment option for acute pain management aligned with the multimodal analgesia now considered standard of care,” the company said in a press release.

The novel co-crystal structure produces a unique pharmacokinetic profile of its active pharmaceutical ingredients compared with their individual or combined administration, according to the pharma maker.

"This innovation is the result of applying a crystallization technology to improve the physicochemical properties and pharmacokinetic characteristics of its active pharmaceutical ingredients,” Carlos Plata-Salamán, M.D., chief scientific officer and chief medical officer of Esteve, said in a statement. “The FDA approval means that clinicians and adult patients in the United States now have a new treatment option for acute pain management."

Seglentis will be commercialized in the United States by KOWA Pharmaceuticals America.