FDA Approved SEGLENTIS®: Innovative API-API Cocrystal Developed by Enantia
On October 15th, 2021, the FDA approved Seglentis for acute pain treatment in adults in the United States. This innovative API-API pharmaceutical cocrystal, discovered at Enantia for ESTEVE Pharmaceuticals, combines two well-known analgesics: celecoxib and racemic tramadol hydrochloride in a 1:1 cocrystal formulated as tablets.
Enantia discovered and developed this novel cocrystal for ESTEVE Pharmaceuticals. KOWA Pharmaceuticals America Inc. licensed the drug for commercialization in the United States, with a launch planned for 2022.
This announcement highlights the increasing relevance of cocrystallization as a strategy to design new drugs. Cocrystals can improve key properties of an API, including solubility and pharmacokinetics. They also create new intellectual property, helping pharmaceutical companies develop new medicines and extend the lifecycle of existing ones.
Picture: Asymmetric unit of the API−API cocrystal formed by tramadol·HCl and celecoxib. https://doi.org/10.1021/acs.cgd.6b01848
The FDA and EMA have both published guidance on the regulatory use of pharmaceutical cocrystals. These guidelines support their role in drug development. SEGLENTIS® now joins other approved cocrystals, such as ENTRESTO® from Novartis, which was approved in 2015 as one of the first API-API cocrystals to reach the market.
Enantia’s Expertise in Pharmaceutical Cocrystals
The approval of SEGLENTIS® is excellent news for the pharmaceutical industry and for R&D companies specializing in new solid forms. Enantia has been a pioneer in cocrystal research and its applications in pharmaceuticals, nutraceuticals, and chemical process development. This approval highlights Enantia’s nearly 20 years of expertise in cocrystal engineering, shown by over 25 patent applications related to cocrystals where the company appears as applicant or inventor.