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

Diclofenac 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. Its systemic absorption is 94% less than the comparable oral Diclofenac treatment.

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.

Approximately 21 million people in the US have osteoarthritis.

Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint. Cartilage cushions the ends of the bones in joints - such as knees, hands, elbows, wrists, ankles and feet - which allows for easy movement. When cartilage erodes, bones can rub together, resulting in pain and loss of free movement in the joint. The most common symptoms include pain, joint soreness, stiffness and deterioration of overall coordination, posture and walking.

The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of treated patients. With all NSAIDs there may be an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. The use of Voltaren Gel is contraindicated in patients with a known hypersensitivity to diclofenac. Voltaren Gel should not be administered to patients who have experienced asthma, urticaria or other allergic-type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Voltaren Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft ( CABG ) surgery.

Voltaren Gel should not be used in combination with other oral NSAIDs or Aspirin because of the potential for increased adverse effects. Similarly, combined use of Voltaren Gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.

Source: Novartis, 2007

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