- ZORVOLEX® is the first low-dose SoluMatrix® diclofenac – a trusted and commonly used NSAID for mild to moderate acute pain and OA pain
- Low-dose SoluMatrix® NSAIDs were developed by Iroko to align with recommendations from FDA, medical organizations, and advocacy groups: use the lowest effective NSAID dose for the shortest period of time
- Effectively managed mild to moderate acute pain and OA pain at low doses
- Was generally well tolerated
- 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
ZORVOLEX®: A Low-dose NSAID Option for Management of Mild to Moderate Acute Pain and Osteoarthritis (OA) Pain
Iroko Pharmaceuticals, LLC, created ZORVOLEX® with appropriate patients in mind:
In addition to being the first low-dose SoluMatrix® diclofenac, data show ZORVOLEX®:
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
Eligible* patients
pay as little as$10
Looking for a low-dose NSAID option to manage mild to moderate acute pain and OA pain?
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.
Potential Risks With NSAIDs
The higher the NSAID dose, the higher the risk of serious side effects.
Risk of Heart Problems
NSAID use may:
Increase the chance of heart attack or stroke in people with or without heart disease or risk factors for heart disease
Risk of Stomach and GI Problems
NSAID use may:
Increase the chance of bleeding, ulcers, and tears (perforations) of the esophagus (the tube leading from the mouth to the stomach), stomach, and intestines
Risk of Kidney Problems
NSAID use may:
Increase the chance of kidney problems, including kidney failure and progressive kidney damage
ZORVOLEX® matters because:
Many patients treated for mild to moderate acute pain and OA pain are treated with an NSAID
Diclofenac is a trusted NSAID that physicians have used for years to help patients with mild to moderate acute pain and OA pain
Although data show diclofenac can help relieve mild to moderate acute pain and OA pain, they also show NSAIDs like diclofenac in high doses can increase risk of serious heart and stomach problems
The higher the NSAID dose, the higher the risk of serious heart and stomach problems
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.