FDA approves Voltaren Arthritis Pain for nonprescription, OTC use
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The FDA has approved Voltaren Arthritis Pain for nonprescription, over-the-counter use, according to a press release.
Voltaren (diclofenac sodium topical gel 1%, GlaxoSmithKline), a NSAID previously available only with a prescription, is intended for the temporary relief of joint pain due to osteoarthritis.
“The approval of OTC diclofenac is overdue,” Leonard H. Calabrese, DO, director of the RJ Fasenmyer Center for Clinical Immunology at the Cleveland Clinic, told Healio Rheumatology in reaction to the announcement. “While modest as a therapeutic, it has good benefits to risks, and for people with OA, affords a small step forward in providing pain relief and self-efficacy.”
Seth Ginsberg, president and co-founder of the nonprofit patient community CreakyJoints, as well as the Global Healthy Living Foundation, similarly welcomed the announcement, stating that the switch will increase access to care and treatment options for patients with OA.
“We are pleased to see a long-time — and often go-to — prescription medicine like Voltaren gel and cream become available over-the-counter as it provides greater access for people who need it,” Ginsberg told Healio Rheumatology. “Many CreakyJoints members use this as part of their treatment protocol to help reduce pain caused by arthritis. However, we always remind our community to consult with a doctor or pharmacist to ensure the safe and effective use of any product, particularly in the context of any prescription and other over-the-counter medications or supplements that they may take.”
According to Ginsberg, Voltaren’s new status will mean that patients will no longer be required to visit to a doctor and gain a prescription to access the drug, saving them time and money.
“As part of the service that pharmacies provide, patients can receive medical information about over-the-counter products free of charge by speaking with their pharmacist,” he added.
However, Ginsberg cautioned that the drug’s new over-the-counter status could result in increased out-of-pocket costs for patients who have previously received it through a pharmacy benefit via their insurance.
“Because this treatment is now over-the-counter, patients who relied on this medicine and received it as part of a pharmacy benefit through their insurance will likely lose that benefit and will be forced to pay out-of-pocket for it,” he said. “For patients currently using insurance to access this product we recommend consulting with their insurance benefit manager for use of tools such as health savings accounts, flexible spending accounts, and/or to seek coupons or discount offers from pharmacies and manufacturers.”
Previously referred to as Voltaren Gel 1%, the drug was first approved by the FDA in 2007 for the relief of the pain of OA of joints responsive to topical treatment, specifically joints in the hands, knees and feet. It has not been demonstrated to work for strains, sprains, bruises or sports injuries.
The FDA changed Voltaren’s status through its Rx-to-OTC switch after data showed that the drug was safe and effective for self-medication use as directed in proposed labeling. In addition, the process requires the manufacturer to demonstrated that patients can understand how to use the drug safely and effectively without the professional supervision.
“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in the press release.
“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription,” she added. “This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.” – by Jason Laday
Disclosures: Leonard Calabrese reports consulting relationships with AbbVie, Centecor Biopharmaceutical, Crescendo Bioscience, GlaxoSmithKline, Horizon Pharma, Janssen Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals and UCB. Ginsberg reports employment with CreakyJoints and the Global Healthy Living Foundation.
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