TIVORBEX now available in U.S. pharmacies for the treatment of acute pain

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced that TIVORBEX® (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), is now available by prescription at pharmacies across the United States. TIVORBEX 20 mg and 40 mg dosage strengths are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market. TIVORBEX is approved by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults¹.

"We are pleased to introduce TIVORBEX, our second low dose SoluMatrix® NSAID, for patients suffering from acute pain," said Lou Vollmer, President of Iroko. "TIVORBEX 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."

Systematic reviews of observational studies have shown that serious NSAID adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds² and renal events such as acute renal failure³ are dose related. 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 goals⁴.

"We are excited to bring TIVORBEX to the community as a low dose option to treat pain in the U.S.," said Dr. Clarence Young, 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."

TIVORBEX 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.

Iroko's ZORVOLEX, also developed using SoluMatrix Fine Particle Technology™, is approved by the U.S. FDA for the management of mild to moderate acute pain and osteoarthritis pain, and is also available by prescription in U.S. pharmacies5.

TIVORBEX is indicated for the treatment of mild to moderate acute pain in adults.

Please see full Prescribing Information for additional important safety and dosing information.