Unique Formulation of Indomethacin Gains FDA Approval


Indomethacin 53-86-1 FDA ApprovalThe recent approval of two low dosage strengths of Indomethacin have been a boon for Iroko Pharmaceuticals. The FDA approved their twenty and forty milligram doses of the popular nonsteroidal anti-inflammatory drug under the brand name Tivorbex. As easy to swallow capsules, the approval of the lower dose Indomethacin will likely lead to fewer adverse effects and greater efficacy, as patients will continue with consistent and appropriate treatment when experiencing fewer side effects. Geared for both mild and moderate pain, the twenty and forty milligram dosages of Indomethacin have analgesic and anti-inflammatory properties, and the new lower dose will be an excellent first line treatment for patients who not only have concerns about NSAID safety, but also for patients who are new to pain management. While practitioners and patients regularly voice concerns over possible adverse effects of treatment with NSAIDs like Indomethacin, such as gastrointestinal discomfort, these newly approved Indomethacin capsules can help ease worries over potential reactions.

The formulation of Indomethacin as Tivorbex is unique in that it is created with submicron particles, twenty times smaller than their original size, that are designed to increase the speed of the dissolution of this drug by increasing the surface area it affects. Two Phase 3 trials heavily influenced the FDA’s decision, with results indicating the effective and analgesic benefits of Indomethacin in patients with acute pain post-surgery. These trials were placebo controlled, multicenter, randomized, double-blind and parallel arm studies. The aforementioned studies compared three dosages of Indomethacin: 20 milligrams three times a day; 40 milligrams two times a day; 40 milligrams three times a day and a placebo. All of the patients involved in these Phase 3 studies were recovering after a bunionectomy and were experiencing significant pain. Of the 835 total participants only the placebo group showed a sizably greater need for concomitant opioid treatment, specifically hydrocodone/acetaminophen 10 milligrams/325 milligrams, as a rescue medication.  A whopping 97 percent of patients in the placebo arm needed rescue opioids, as compared to 76 percent of the patients who received forty milligrams of Indomethacin twice a day.

LGM Pharma provides Indomethacin CAS# 53-86-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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