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First Topical Prescription
Treatment For Osteoarthritis Pain, Voltaren Gel Receives FDA Approval
edited by Joint-Pain-Forum.com
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
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.
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
Osteoarthritis is a chronic condition
characterized by the breakdown of cartilage in the joint.
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
"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.
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
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)
www.Joint-Pain-Forum.com from original press release.
About Voltaren Gel
Gel provides 1% 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 favorable safety profile as its systemic
absorption is 94% less than comparable oral diclofenac treatment.
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.
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.
Gel is contraindicated for the treatment of peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery.
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
Voltaren Gel joins other available
Voltaren prescription medications in the US as well as the Novartis
global portfolio of Voltaren Emulgel products. For full prescribing
information, visit www.voltarengel.com.
The foregoing release contains forward-looking
statements that can be identified by terminology such as "will," "often
leads to," "may be," "can be," or similar expressions, or by express or
implied discussions regarding potential future revenues from Voltaren
Gel. Such forward-looking statements reflect the current views of the
Company regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Voltaren Gel will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding commercialization of Voltaren Gel could be affected by, among
other things, unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing
clinical data, competition in general, increased government, industry
and general public pricing pressures, unexpected regulatory actions or
delays or government regulation generally, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the U.S.
Securities and Exchange Commission. Should one or more of these risks
or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the information
in this press release as of this date and does not undertake any
obligation to update any forward-looking statements contained in this
press release as a result of new information, future events or
AG (NYSE: NVS) is a world leader in offering medicines to protect
health, cure disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients,
ease suffering and enhance the quality of life. We are strengthening
our medicine-based portfolio, which is focused on strategic growth
platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, human vaccines and leading self-medication OTC
brands. Novartis is the only company with leadership positions in these
areas. In 2006, the Group's businesses achieved net sales of USD 37.0
billion and net income of USD 7.2 billion. Approximately USD 5.4
billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 100,000
associates and operate in over 140 countries around the world. For more
information, please visit our website at http://www.novartis.com/.
U.S. Centers for Disease Control and
Prevention (CDC). Arthritis Related Statistics. Accessed on
October 17, 2007.
2 National Institute of
Arthritis Musculoskeletal and Skin Diseases (NIAMS), National
Institutes of Health, U.S. Department of Health and Human Services. Handout on Health: Osteoarthritis.
Accessed on October 17, 2007.
Arthritis Foundation. Accessed on October 17, 2007.
U.S. Centers for Disease Control and Prevention (CDC). [CDC (2007)
Update: National and State Medical Expenditures and Lost Earnings
Attributable to Arthritis and Other Rheumatic Conditions -- United
States, 2003. MMWR Morb Mortal Wkly Rep, 56(01):4-7].
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