News Feature | March 5, 2014

FDA Approves Iroko Pharmaceutical's Tivorbex For Analgesia

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By Cyndi Root

Iroko Pharmaceuticals, LLC announced in a press release that the Food and Drug Administration (FDA) has approved Tivorbex (indomethacin) capsules. The nonsteroidal anti-inflammatory drug (NSAID) is approved for 20 mg and 40 mg doses, lower doses than other indomethacin products in circulation. The drug treats mild to moderate pain. Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals, said, “Indomethacin has potent anti-inflammatory and analgesic properties, but, like other NSAIDs, it can also be associated with dose-related serious adverse events. When available, Tivorbex will allow healthcare professionals to have a lower dose formulation of this well-established NSAID.”

Analgesia

Analgesic drugs are painkillers. The term is derived from the Greek, meaning without pain. These therapeutic agents have varying action mechanisms, working on the peripheral and central nervous systems. Analgesics include NSAIDs, narcotics, and agents like acetaminophen. Pain relievers are needed for many conditions, acute injuries, and surgeries.

Tivorbex

Tivorbex is receiving attention due to its low dose. NSAIDS carry risks for adverse events like stroke, myocardial infarction, gastrointestinal disorders, and kidney failure. Most issues are related to dosing and overdosing. Many medical organizations recommend dosing patients with the least plausible dose consistent with treatment goals.

John Vavricka, President and CEO of Iroko Pharmaceuticals, said, “Tivorbex is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology.” Tivorbex is different than other indomethacin products due to the nanotechnology.  The drug is formulated with submicron particles, which increases the surface area available for faster dissolution. The NSAID is broken down into much smaller particles, 200 to 800 nm in diameter, up to 20% smaller than the original size.

The FDA approved Tivorbex on the strength of two Phase 3 clinical trials.  The placebo-controlled and multi-center trials demonstrated significant pain relief. Study participants had acute pain after surgery.

About Iroko

Iroko Pharmaceuticals is a globally positioned specialty company focused on pain management. The company is using existing analgesics and improving them with new technologies. The company operates from the Navy Yard in Philadelphia and has drug discovery and marketing efforts in over 40 countries.