ZORVOLEX: The lowest FDA-approved dose of diclofenac available (18 mg)
ZORVOLEX is the first low-dose SoluMatrix® diclofenac for mild to moderate acute pain or osteoarthritis pain approved by the US Food and Drug Administration (FDA).
ZORVOLEX: A low-dose SoluMatrix® NSAID for management of mild to moderate acute pain or osteoarthritis pain
Iroko created ZORVOLEX with appropriate patients in mind:
- ZORVOLEX is the first low-dose SoluMatrix® diclofenac
- Diclofenac is a trusted and commonly used NSAID for mild to moderate acute pain or osteoarthritis pain
- Low-dose SoluMatrix® NSAIDs were developed by Iroko to align with recommendations from FDA, medical organizations, and advocacy groups: Use the lowest NSAID dose possible for the shortest time needed for your treatment
In addition to being the first low-dose SoluMatrix® diclofenac available, clinical studies demonstrated that ZORVOLEX:
- Effectively managed mild to moderate acute pain or osteoarthritis pain at low doses
- Was generally well tolerated
ZORVOLEX was developed using SoluMatrix Fine Particle Technology™, a proprietary technology used to create NSAID drug particles that are approximately 10 to 20 times smaller than their original size.
- Helps drugs dissolve quickly so they can be rapidly absorbed in the body
Original NSAID particles
SoluMatrix® NSAID particles
See how SoluMatrix Fine Particle Technology™ reduces the size of drug particles!
Eligible* patients
pay as little as$10
Looking for a low-dose NSAID option to manage mild to moderate acute pain or OA pain?
NSAID use and FDA: Warnings and recommendations
Over the past decade, the FDA has monitored and evaluated the safety of NSAIDs.
In 2005, FDA required manufacturers of all prescription NSAIDs to include a Boxed Warning and a Medication Guide:
- 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
- FDA recommended using the lowest NSAID dose possible for the shortest time needed for your treatment
ZORVOLEX® approved
In July 2015, FDA strengthened the Boxed Warning to include statements that non-aspirin NSAIDs increase the chance of a heart attack or stroke. FDA is requiring all manufacturers of all prescription NSAID pain relievers—including medications like ibuprofen (Motrin®), celecoxib (Celebrex®), and naproxen (Naprosyn®)—to include updated safety language within their product labels.
Starting in May 2016, prescription NSAID labels now reflect the following information:
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID
- The risk may increase with longer use of the NSAID
- The risk appears greater at higher doses
- NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease
FDA recommends that NSAIDs be used at the lowest possible dose for the shortest time needed.
- The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID
Other healthcare-related organizations support FDA recommendations
In addition to FDA, professional medical organizations and patient advocacy groups also recognize the importance of using the lowest effective NSAID dosage for the shortest duration:
- American Heart Association
- American College of Cardiology
- National Kidney Foundation
- American College of Rheumatology
Potential risks associated with NSAID use
The higher the NSAID dose, the higher the risk of certain serious side effects
Risk of heart problems
Increased NSAID doses may increase:
The risk of heart attack or stroke in people with or without heart disease or risk factors for heart disease
Risk of stomach and GI problems
Increased NSAID doses may increase:
The risk 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
Increased NSAID doses may increase:
The risk of kidney problems, including kidney failure
ZORVOLEX® matters because:
Many patients treated for mild to moderate acute pain or osteoarthritis pain are treated with an NSAID
Diclofenac is a trusted NSAID physicians commonly use to help patients with acute pain or osteoarthritis pain
While NSAIDs including diclofenac can help manage pain and reduce inflammation, studies have shown they can potentially lead to certain serious side effects involving the heart, stomach, and kidneys
The risk of certain serious side effects increases with increasing doses and longer use of NSAIDs
FDA recommends that NSAIDs be used:
- Exactly as your doctor prescribes them
- At the lowest dose possible for your treatment
- For the shortest time needed
ZORVOLEX (18 mg) provides the lowest available dose of diclofenac.