- The result: low-dose NSAID pain medicine that is rapidly absorbed by the body
- The boxed warning highlighted the potential for increased risk of serious cardiovascular (CV) events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use
- The FDA specifically recommended taking the lowest effective NSAID dose for the shortest period of time
ZORVOLEX® 18 mg: The Lowest FDA-approved Dose of Diclofenac Available
ZORVOLEX® is the first US Food and Drug Administration (FDA) – approved low-dose SoluMatrix® diclofenac for mild to moderate acute pain and OA pain
Iroko Pharmaceuticals, LLC, created ZORVOLEX® with SoluMatrix Fine Particle Technology™, an innovative scientific process that creates NSAID drug particles that are approximately 10- to 20-times smaller than their original size.
Original NSAID particles
SoluMatrix® NSAID particles
NSAIDs and the FDA: Warnings and Recommendations
Over the past decade, the FDA has monitored and evaluated the safety of NSAIDs
In 2005, based on new evidence about NSAID risks, the FDA began requiring manufacturers of prescription NSAIDs to include new safety warnings:
In July 2015, the FDA strengthened its warning about NSAID use to emphasize that patients taking NSAIDs are at greater risk for heart attack or stroke.
ZORVOLEX® matters because:
The FDA recommends that patients take the lowest effective NSAID dose for the shortest period of time.
ZORVOLEX® 18 mg three times daily offers the lowest effective diclofenac dosage for managing mild to moderate acute pain.