Case Study : Rx-to-OTC switch of Voltaren arthritis pain

In this article we will be understanding about the Rx-to-OTC switch of Voltaren arthritis pain. It is one of the drug which The US Food and Drug Administration (FDA) approved three drugs for nonprescription, or over-the-counter (OTC).

Rx-to-OTC switch

• The process of changing the status of a drug from prescription to nonprescription is called an Rx-to-OTC switch.
• It is usually initiated by the manufacturer of the prescription drug.
• For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
• 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. 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.
• Voltaren arthritis pain 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. 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.

Basis of Rx-to-OTC switch approval

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.

Voltaren arthritis pain

• The active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin at the application site to deliver arthritis pain relief. Voltaren Arthritis Pain offers consumers who suffer from OA an alternative option to oral analgesics.  It targets pain directly at the site and the amount of diclofenac sodium that is systemically absorbed from Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of diclofenac sodium. GSK anticipates Voltaren Arthritis Pain will be available on US shelves in Spring 2020.
• This product, previously referred to as Voltaren Gel 1%, was first approved by the FDA in 2007 as a prescription drug and was indicated for the relief of the pain of osteoarthritis of joints responsive to topical treatment, in particular, the joints of the hands, knees and feet. It has not been shown to work for strains, sprains, bruises or sports injuries.
• Voltaren arthritis pain is intended for the temporary relief of joint pain due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the US, and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of your joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint.
• Voltaren arthritis pain is not for immediate relief and may take up to 7 days to work. Consumers should stop use and seek medical attention if their arthritis pain is not improved in 7 days or they need to use the product for more than 21 days. The active ingredient in Voltaren Arthritis Pain, diclofenac, may cause a severe allergic reaction, especially in people allergic to aspirin. If an allergic reaction occurs, consumers are advised to stop use and seek medical care immediately. Liver damage may occur if this product is used more or longer than directed or when using other products containing diclofenac.
• This product contains an NSAID, which may cause severe stomach bleeding. NSAIDS, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if consumers use more than directed or for longer than directed. If pregnant or breastfeeding, consumers should talk to a health care professional about use. This product should not be used during the last 3 months of pregnancy unless the consumer is definitely directed to do so by a doctor because diclofenac may cause problems in the unborn child or complications during the delivery.