First Topical Prescription Treatment For Osteoarthritis Pain, Voltaren Gel Receives FDA Approval

October 23, 2007 – 8:31 pm | posted in Arthritis

* First US approval for a prescription NSAID (non-steroidal anti-inflammatory drug) treatment that can be applied directly to site of osteoarthritis pain

* Voltaren Gel is the only prescription topical medication proven to significantly reduce osteoarthritis pain in both the knees and the joints of the hands

* Offers highly effective pain relief with minimal drug absorption throughout the body — shown to be 94% less than comparable oral diclofenac treatment

Voltaren® Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.

The US Food and Drug Administration (FDA) granted the approval to Novartis for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.

Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body’s most commonly affected joints. It is the first prescription topical osteoarthritis treatment to have proven its effectiveness in both the knees and joints of the hands through clinical trials. Voltaren Gel delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment.

“Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favorable safety profile. The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offering patients an alternative to oral therapies,” said Roy Altman, MD, Professor of Medicine in the Division of Rheumatology and Immunology at UCLA in Los Angeles and Past President of the Osteoarthritis Research Society International. “Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects.”

The efficacy and safety of Voltaren Gel were studied in more than 900 patients with knee or hand osteoarthritis. The US approval was based on several studies, including the results of two randomized, double-blind, placebo-controlled efficacy studies and a 12-month safety study.

Voltaren Gel was shown to significantly reduce pain in hand and knee osteoarthritis, with pain relief sustained through the end of treatment. After six weeks of treatment in an efficacy study of patients with osteoarthritis of the hand, results showed that pain levels were reduced by nearly half (46%). In a 12-week study in patients with osteoarthritis of the knee, Voltaren Gel showed a 51% reduction in pain.

“Voltaren Gel represents an important clinical milestone — it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands,” said Jorge Insuasty, MD, Senior Vice President, Research and Development, Novartis Consumer Health, Inc. “Patients now have the option to effectively treat osteoarthritis pain directly at the source with favorable tolerability.”

Approximately 21 million people in the US have osteoarthritis,(1) and the aging population in the US means 72 million more will be at risk for developing the condition by 2030.(2) Osteoarthritis is a chronic, painful condition that often leads to working limitations and reduced overall health.(3)

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