Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were created for use in acute bouts of pain, rather than long term relief. The American Chronic Pain Association suggests the recommended way to use NSAIDs is to take the lowest effective dose for the shortest period of time. But for many arthritis patients- there is no “shortest period of time.” The pain continues indefinitely, and NSAIDs often provide the best continued mitigation. Increased exposure to NSAID drugs has been associated with a variety of adverse events including gastrointestinal bleeding, and possibly increased risk of heart attack and stroke.
In an effort to improve safety without eroding efficacy of the drug in terms of pain relief, Iroko Pharmaceuticals has developed an NSAID pain medication, Zorvolex, which is effective at lower doses than the commonly used ibuprofen. This limits the patient’s exposure to the drug. A tablet of ibuprofen is 200mg, while a tablet of Zorvolex is 35mg. The drug used a technology called SoluMatrix Fine Particle technology which allows the drug to be absorbed faster, so a lower dose is required to produce an analgesic effect.
The company just completed a phase III, 12-month, open-label safety study to show that the drug is just as safe for long term use. While the study did not compare the safety of these doses directly to average doses of other NSAIDs, the current safety studies on other NSAIDs show lower doses lead to fewer adverse events.
“This is an option for patients and their physicians if they’re considering using NSAIDs.” said Clarence Young, MD, Chief Medical Officer at Iroko Pharmaceuticals.