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FDA Approves Seglentis

FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Pain

October 18, 2021 -- The U.S. Food and Drug Administration (FDA) approved Seglentis (celecoxib and tramadol hydrochloride), a proprietary product developed by Esteve Pharmaceuticals' R&D team. It is an innovative first-in-class product comprised of a co-crystal form of celecoxib (an anti-inflammatory) and tramadol (an analgesic) for the treatment of acute pain in adults.1-9 This is Esteve's first proprietary research product to enter the United States market.
In words of Dr. Carlos Plata-Salamán, Chief Scientific Officer and Chief Medical Officer of Esteve "This innovation is the result of applying a crystallization technology to improve the physicochemical properties and pharmacokinetic characteristics of its active pharmaceutical ingredients.1,2,4,7,9 The FDA approval means that clinicians and adult patients in the U.S. now have a new treatment option for acute pain management."

Seglentis is the trade name for tablets that contain a co-crystal7 composed of celecoxib and tramadol hydrochloride. It is a new analgesic designed for acute pain management in a multimodal treatment approach3,5,6 targeting four complementary pain relief mechanisms.5,6 It offers a new treatment option for acute pain management aligned with the multimodal analgesia now considered standard of care.8

The novel co-crystal structure produces a unique pharmacokinetic profile of its active pharmaceutical ingredients compared to their individual or combined administration.1,2,4,9 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 patientÂ’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.


References

  1. 1. British Journal of Clinical Pharmacology. 2017;83(12):2718-2728.
    2. British Journal of Clinical Pharmacology. 2018;84(1):64-78.
    3. Drugs in R&D. 2018;18(2):137-148.
    4. Clinical Drug Investigation. 2018;38(9):819-827.
    5. Expert Opinion on Investigational Drugs. 2019;28(5):399-409.
    6. Journal of Pain Research. 2019;12:2679-2689.
    7. Crystal Growth & Design. 2017;17(4):1884-1892 and 2019;19(6):3172-3182.
    8. Journal of Pain. 2016;17(2):131-157.
    9. Clinical Therapeutics. 2021;43(6):1051-1065.

Source: Esteve

Posted: October 2021

Seglentis (celecoxib and tramadol hydrochloride) FDA Approval History

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