The U.S. Food and Drug Administration (FDA) approved Seglentis® (celecoxib and tramadol hydrochloride), a proprietary product developed by ESTEVE’s R&D team. This is ESTEVE's, CataloniaBio & HealthTech member, first proprietary research product to enter the United States market.
Seglentis® is the trade name for tablets that contain a co-crystal composed of celecoxib and tramadol hydrochloride. It is a new analgesic designed for acute pain management in a multimodal treatment approach targeting four complementary pain relief mechanisms. It offers a new treatment option for acute pain management aligned with the multimodal analgesia now considered standard of care.
The New Drug Application (NDA) was approved by the U.S. FDA on October 15, 2021. Staffan Schüberg, Chief Executive Officer of ESTEVE, said: "We are proud of this milestone as we understand it as a recognition of our daily efforts to meet patient’s needs and to address the challenges the pain community is facing nowadays". Seglentis® will be commercialized in the United States by KOWA Pharmaceuticals America, Inc.
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