Spanning the field of pain, inflammation and oncology, as well as more recently for unwanted reasons, cardiovascular disease the cyclooxygenase-2 (COX-2 or Coxibs) have sat in the spot light for almost a decade now.
The first Coxib, Celebrex (celecoxib), arrived on the market in 1998 rapidly becoming a blockbuster soon to be followed by another equally successful drug from the same class, Vioxx (rofecoxib). Soon after however, cardiovascular adverse effects were found to be associated with Vioxx leading to its withdrawal and sparking the start of a turbulent period affecting not only Vioxx, but the Coxib class as a whole and more generally all NSAIDs.
LeadDiscovery’s report Coxibs - Past Problems…Future Potential was written to provide all in the drug development sector a detailed look at the events leading up to the withdrawal of Vioxx, the status of the Coxib class 2 years on and its future potential.
Far from slipping into the pharmaceutical backwater this class continues to provide blockbuster revenues for Pfizer and potential for others. This report is key to companies considering reentry into the COX-2 arena and those developing other analgesics that could canabilize the coxib market. The report is also written with the aim of guiding companies investing in chemoprevention and Alzheimer’s disease, indications that have been investigated as target for the Coxibs.
Against a backdrop of litigations brought against Merck & Co and new regulatory guidelines for the coxibs, Pfizer’s Celebrex generated $1.7 billion in revenue last year and continues to win approval for new indications, the most recent being ankylosing spondylitis. The continued potential of the Coxibs is evidenced by clear activity of this class in the prevention of certain pre-cancerous growths and uncertainty over the cardiovascular safety of NSAIDs. Most recently data has emerged offering a possible explanation behind the cardiovascular activity of the Coxibs offering the potential to rationally design new agents with improved therapeutic margins.
Coxibs - Past Problems...Future Potential is designed to help readers address questions such as:
What trials have been conducted and what do they mean?
How does the use of an NSAID plus a gastroprotective agent compare to that of a Coxib with respect to gastrointestinal safety?
What is the cardiovascular risk attached to the Coxibs - is the risk simply a reflection of the comparator used in pivotal trials?
Do the Coxibs still offer an advantage over NSAIDs
What is the mechanism of increased cardiovascular events, what is their time frame and how can they be minimized?
What is the regulatory view on the Coxib class and NSAIDs?
Is the development of Coxibs for the prevention/treatment of cancer or Alzheimer’s disease justifiable?
What is the current status of approved and pipeline Coxibs?
How has the Coxib market changed since 2003?
Should companies attempt to develop new Coxibs?
If so what should be the developmental goals and what should be the indications?
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