Pennsaid
Pennsaid, the Company's lead product, is used to treat the signs and symptoms of osteoarthritis (OA) of the knee. The drug combines a transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with diclofenac sodium, a leading non-steroidal anti inflammatory drug (NSAID) and delivers the active drug through the skin directly to the site of pain. While conventional oral NSAIDs expose patients to potentially serious systemic side effects, Nuvo's clinical trials suggest that some of these systemic side effects may occur less frequently with topically applied Pennsaid,
while providing a similar degree of symptom relief. Pennsaid is available only by prescription where approved.
Pennsaid was first approved in the U.K. in 2000 and has been marketed for several years in the U.K., Canada and several European countries. In November 2009, the U.S. Food and Drug Administration (FDA) approved Nuvo's New Drug Application for Pennsaid. Nuvo’s U.S. licensee Mallinckrodt Inc., a Covidien plc company, a leading global provider of healthcare products launched Pennsaid in the U.S. in April 2010. Additional information for U.S. patients and physicians is available at www.pennsaid.com.
In Canada, Pennsaid is marketed by Paladin Labs Inc. and patients and physicians residing in Canada, can visit the Paladin Patient Information Centre for additional information. In Europe, Pennsaid is available by prescription in a number of countries, including Greece (Vianex SA), Italy (Italchimichi S.p.A.) and the United Kingdom (Movianto UK Limited).
A National Institute of Health (NIH) epidemiology publication reported that 26.9 million American adults aged 25 and older suffer with clinical OA. In adults, arthritis is one of the leading causes of disability and is among the most common conditions resulting in work limitations. According to the Arthritis Foundation (AF) most Americans are unaware of the seriousness of arthritis and the substantial negative impact it can have on an individual's quality of life and use of health-care resources. They estimate that it costs the U.S. economy more than $128 billion annually. According to the AF, knee osteoarthritis, the most frequent form of lower extremity arthritis, contributes to 418,000 knee replacement procedures annually and in 2006 accounted for $19 billion in hospital charges.
