Zorvolex (diclofenac) - What You Should Know

What Makes Zorvolex Different?

Zorvolex. Credit: Lisa J. Goodman/Moment Mobile/Getty Images

Zorvolex is a low-dose, quick-dissolving form of diclofenac, an NSAID (nonsteroidal anti-inflammatory drug). It was approved for the treatment of osteoarthritis pain in 2014. What makes it different from other forms of diclofenac and other NSAIDs?

Zorvolex, produced by Iroko Pharmaceuticals, LLC, was previously approved for the treatment of mild to moderate acute pain in adults. The approval for osteoarthritis pain is an additional indication, Since not all medications and treatments are equally effective for any given individual, it was welcomed as a new option for osteoarthritis patients.

How Zorvolex is Different from Other Forms of Diclofenac

How is Zorvolex different from generic diclofenac and the brand name form, Voltaren, which is a form of diclofenac, and the generic diclofenac? Zorvolex is formulated with submicron particles of diclofenac. The submicron particles are about 20 times smaller than the size found in the other diclofenac medications. The submicron particles, developed using SoluMatrix Fine Particle Technology (TM), allow the drug to dissolve more quickly. Zorvolex is the first low-dose NSAID (nonsteroidal anti-inflammatory drug) developed using SoluMatrix Fine Particle Technology (TM) that has been approved by the FDA.

Need for Low-Dose NSAIDs

A low-dose NSAID helps address FDA warnings and recommendations. Several years ago, the FDA updated and increased warnings for all NSAID drugs. It was clearly stated that NSAIDs are associated with an increased risk of cardiovascular problems (e.g., heart attack and stroke) and potentially fatal gastrointestinal bleeding.

Around that time, two COX-2 selective NSAIDs -- Vioxx (rofecoxib) and Bextra (valdecoxib) -- were pulled from the market, but most remained. The FDA also advised doctors to prescribe (and patients to use) the lowest effective dose of an NSAID for the shortest duration possible, while taking into consideration the therapeutic goal.


Administration of Zorvolex

The recommended dosage of Zorvolex (an oral drug) for osteoarthritis pain is 35 mg. three times a day. (Note: Zorvolex capsules are not interchangeable with Voltaren or generic diclofenac pills. The dosage and strength is not equivalent.) Zorvolex 35 mg. is a blue and green capsule with IP-204 imprinted on the body and 35 mg on the cap in white ink.

Taking Zorvolex with food may decrease effectiveness -- it has not been studied. Also, patients with known hepatic (liver) disease may require a dosage adjustment.

Common Adverse Reactions of Zorvolex

Based on clinical trials, the most common adverse events associated with Zorvolex include ​edema, nausea, headache, dizziness, vomiting, constipation, pruritis, diarrhea, flatulence, pain in extremities, abdominal pain, sinusitis, increased ALT (alanine aminotransferase), increased blood creatinine, hypertension, and indigestion.

Contraindications for Zorvolex

Patients who should not take Zorvolex include: those with a known hypersensitivity to diclofenac;  patients who have had asthma, hives, or any allergic reaction after taking aspirin or any NSAID; and those having pain associated with coronary artery bypass graft surgery.

Warnings and Precautions for Zorvolex

The usual warnings associated with all other NSAIDs, with regard to increased risk of cardiovascular events and gastrointestinal ulcers and bleeding, also apply to Zorvolex. Caution must be exercised if patients with a previous history of gastrointestinal ulcers or bleeding are prescribed Zorvolex. Blood tests for liver function should be performed periodically to check for abnormalities. Patients taking Zorvolex should also be monitored for hypertension, fluid retention, edema, and kidney function. Anaphylactoid and severe skin reactions are also a possibility.

Zorvolex should not be taken with aspirin since doing so would increase the risk of gastrointestinal bleeding. Similarly, Zorvolex should not be taken with anticoagulants because it too would increase the risk. If you already are taking an ACE inhibitor, diuretic, lithium, cyclosporine, or methotrexate, caution must be used because drug interaction can occur.

For women who are pregnant, animal studies revealed that Zorvolex may cause harm to the fetus. After 30 weeks gestation, the drug should not be taken. Studies also revealed that the drug may be found in the human milk of nursing mothers.


Prescribing Information. Zorvolex. Published August 2014.

FDA Approves Zorvolex for the Treatment of Osteoarthritis Pain. HCPLive. August 25, 2014.

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