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Voltaren gel receives USFDA approval PDF Print E-mail
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Tuesday, 23 October 2007

Voltaren gel has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis. Voltaren Gel, is a non-steroidal anti-inflammatory (NSAID) medication

Voltaren gel (diclofenac sodium topical gel) 1 percent 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 (USFDA) granted the approval 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 topical osteoarthritis treatment to have proven its effectiveness in both the hands and knees through clinical trials.  Voltaren Gel, which will be marketed in the US by the OTC business unit since this is the case in many other countries, delivers effective pain relief with a favorable safety profile as its systemic absorption is 94 percent less than the comparable oral diclofenac treatment.

 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 percent). In a 12-week study in patients with osteoarthritis of the knee, Voltaren gel showed a 51 percent reduction in pain.

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

 
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