Voltaren Gel (diclofenac sodium topical gel) 1 per cent 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 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 favourable safety profile as its systemic absorption is 94 per cent less than the comparable oral diclofenac treatment.
"Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favourable safety profile. The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offering patients an alternative to oral therapies. Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects," 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.
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 randomised, 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 per cent). In a 12-week study in patients with osteoarthritis of the knee, Voltaren Gel showed a 51 per cent 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. Patients now have the option to effectively treat osteoarthritis pain at the source with favourable tolerability," said Jorge Insuasty, MD, senior vice president, Research and Development in the Group's OTC business unit.
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.
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. Arthritis and related conditions, such as osteoarthritis, cost the US economy nearly USD 128 billion per year in medical care and indirect expenses, including lost wages and production. Despite the high prevalence of osteoarthritis, there is no cure for this disease, which tends to progressively reduce mobility and the overall health state in the affected patients.
Voltaren Gel provides 1 per cent diclofenac sodium in a topical gel formulation. It is a non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands. Voltaren Gel delivers highly effective pain relief with a favourable safety profile, as its systemic absorption is 94 per cent less than comparable oral diclofenac treatment.
The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7 per cent 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.