Low-Dose Indomethacin (Tivorbex) Now Available
The lower-dose formulation of indomethacin (Tivobrex) is now available in pharmacies in the US. Tivobrex, which was first approved in March 2014, is designed to reduce the adverse effects of nonsteroidal anti-inflammatory drugs (NSAIDs).
Tivobrex contains indomethacin as “submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution,” according to Iroko Pharmaceuticals.1
Physicians can now prescribe a 20 mg or 40 mg dosage strength of Tivobrex for the treatment of mild to moderate acute pain in adults—making this the lowest dose of indomethacin available. "We are pleased to introduce Tivobrex, our second low dose SoluMatrix NSAID, for patients suffering from acute pain," said Lou Vollmer, President of Iroko in a press release. "Tivobrex joins Zorvolex [diclofenac] capsules, a low-dose formulation of diclofenac, in our growing portfolio and signifies Iroko's commitment to developing low dose NSAID options for patients."
Adverse events associated with NSAIDs have been associated with more deaths per year than opioids. Systematic reviews of observational studies have shown that serious NSAID adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds and renal events such as acute renal failure are dose related, said the company.2
This prompted the FDA and professional medical organizations including the American Heart Association, American Gastroenterological Association, and The American College of Rheumatology, to recommend that NSAIDs be used at the lowest effective dose for the shortest possible duration of time consistent with individual patient treatment goals, noted the company.3,4
"We are excited to bring Tivorbex to the community as a low-dose option to treat pain in the US," said Clarence Young, MD, Chief Medical Officer of Iroko Pharmaceuticals. "Tivorbex has demonstrated significant pain relief at the lowest dose of indomethacin available, and this launch brings us another step further in addressing the need for efficacious, yet low dose, NSAID treatment options for pain management."