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Diclofenac Sodium

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Overview
Product Profile
Data

Diffucaps^® Diclofenac Sodium ER (once daily)

Our Diffucaps Diclofenac Sodium ER offers a once-daily dosing option of a
leading NSAID, providing patient convenience and 24 hours of therapeutic
effect.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) prescribed globally to relieve inflammation and as an analgesic reducing pain in conditions such as osteoarthritis, rheumatoid arthritis, acute injury, low back pain, ankylosing spondylitis (chronic inflamed joints), acute musculo-skeletal disorders, and acute gout.

Continued Category Growth Expected

Pain category global drug sales are expected to grow to $32.8 billion by 2013.¹ These numbers include an estimated 102 million chronic pain sufferers across the seven major pharmaceutical markets (U.S., Japan, UK, France, Germany, Italy, Spain).² Key emerging markets also continue to show category growth.³

Opportunities to Strengthen Your Portfolio

Once-daily Diffucaps Diclofenac Sodium provides the opportunity to commercialize the most widely prescribed NSAID worldwide in extended-release formulation for the symptoms of chronic pain conditions.⁴ Our formulation has the added benefit of promoting patient compliance by reducing the number of daily doses.⁵

The flexible Diffucaps^® technology, which was leveraged to create this once-daily formulation, also enables opportunities to create new combination products with Diclofenac Sodium. Possibilities include combining the benefits for Diclofenac Sodium with a muscle relaxant or anti-ulcerant for enhanced treatment effects.

Diffucaps^® Diclofenac Sodium ER (once daily)

Therapeutic Category	Pain
Indication	Non-steroidal anti-inflammatory agent
Development Status	Commercialized; Licensing opportunities available
Available Dosage Strength(s)	75 mg 100 mg
Product Description	Extended-release (once-daily) formulation of sodium diclofenac
Technology	Diffucaps^® - Customized Drug Release technology
Licensing Opportunities	Aptalis Pharmaceutical Technologies is seeking licensing partners for global opportunities.

Diffucaps^® Diclofenac Sodium ER (once daily)

Currently marketed in several European countries.
Diclofenac Sodium ER dosed once-daily was shown to be therapeutically
equivalent to reference products Voltaren Retard and Voltarol SR 75 in clinical studies.⁶

The extended-release product provided a continuous therapeutic effect for 24 hours with safety and tolerability.⁶

This information is provided solely for the purpose of the evaluation of business opportunities by potential collaboration partners. The information is based on currently existing data and marketing authorizations in a number of jurisdictions and should not be assumed to be approved by regulatory authorities in any individual country. Consumers should consult with their individual physician for product information and should not rely upon any information provided here.

For more information on this product, please contact Aptalis Pharmaceutical Technologies.

Press Release. Global Market for Pain Management Pharmaceuticals Worth $32.8 Billion in 2013. BCC Research. Accessed July 2010. http://www.bccresearch.com/pressroom/HLC026C.html
DMHC2584: Stakeholder Opinions: Targeting Nerve Growth Factor For Pain Therapy (03/2010)
DMHC2444:Commercial Insight: Pain Market Overview (10/2008). Datamonitor.
Cannon CP, Curtis SP, FitzGerald GA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771-1781.
Kardas P. Comparison of patient compliance with once-daily and twice-daily antibiotic regimens in respiratory tract infections: results of a randomized trial. J Antimicrob Chemother. 2007;59:531-536.
Aptalis Pharmaceutical Technologies Data on File