March 2007
In the Pipeline
Stay up to date on the latest arthritis drugs being developed by pharmaceutical companies and/or reviewed by the Food and Drug Administration (FDA).
March 2007
Several New Drugs for 2007
Posted 3/21/2007
Etoricoxib (Arcoxia) is an investigational, selective COX-2 inhibitor for the treatment of osteoarthritis. An decision from the FDA regarding the new drug application is expected in April 2007.
Zoledronic acid (Aclasta) is a once-yearly bisphosphonate intravenous (IV) infusion for the treatment of postmenopausal osteoporosis. A new drug application was submitted in November 2006 and a decision is expected by July 2007.
Lumiracoxib (Prexige) is an investigational, selective COX-2 inhibitor for the treatment of osteoarthritis and acute pain. It has been shown to reduce the incidence of serious upper gastrointestinal complications compared with traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Short-term (4 weeks) use of lumiracoxib had less effect on increasing blood pressure compared to traditional NSAIDs. Thrombotic cardiovascular events were also low and comparable between lumiracoxib and traditional NSAIDs. The new drug application is due to be submitted to the FDA by the end of first quarter 2007.
Milnacipran is a norepinephrine-serotonin reuptake inhibitor. It is indicated for the treatment of fibromyalgia syndrome. Although Phase II studies demonstrated efficacy in reducing pain frequency and intensity compared to placebo, the first Phase III study did not meet its specified endpoint. Despite the findings in the first Phase III study, two more ongoing Phase III trials will be completed and a new drug application is scheduled to be submitted to the FDA by late 2007.
Tocilizumab (Actemra) is the first humanized anti-interleukin-6 receptor monoclonal antibody to be studied as a potential treatment for rheumatoid arthritis. A new drug application is planned for some time during 2007.
New Lupus Drug in Phase III
Posted 3/19/2007
Positive interim results have been announced from a Phase III trial of abetimus sodium (Riquent), a drug candidate for systemic lupus erythematosus. The study is designed to assess the ability of abetimus sodium to prevent or delay the time to renal flare in lupus patients with a history of renal disease. The medication's only known biologic activity is the reduction of circulating levels of anti-dsDNA antibodies. Although clinical benefit has not yet been proven, abetimus sodium treatment has significantly reduced these antibody levels in all clinical trials where they were measured.
Topical NSAID Nearing FDA Approval
Posted 3/13/2007
Diclofenac sodium solution (Pennsaid), a topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis, could be approved by the FDA once certain conditions are satisfied. New studies to support those conditions are planned to begin in the fourth quarter of 2007. Pennsaid is currently approved for the treatment of osteoarthritis in Canada and several European countries. The product allows diclofenac to be delivered to a specific site through the skin and may limit complications associated with systemic delivery. There is currently no topical NSAID product approved in the U.S.
Epratuzumab granted Fast Track by FDA for trials for the treatment of SLE
Posted 3/9/2007
Epratuzumab, a humanized monoclonal antibody against the CD22 marker expressed on activated B-cells, is being evaluated in two international Phase III ("ALLEVIATE A and B") trials for the treatment of moderate and severe systemic lupus erythematosus. The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE. A phase II trial testing epratuzumab in the treatment of Sjögren’s syndrome has recently been completed as well.
Humira approved for use in Crohn's disease (inflammatory bowel disease)
Posted 3/1/2007
Already approved for use in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, the tumor necrosis factor alpha inhibitor adalimumab (Humira) has now been approved for the treatment of inflammatory bowel disease (also called Crohn's disease). As many as 20 percent of people with inflammatory bowel disease develop arthritis.
For Your Information
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer:
- In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- In Phase IV studies, the post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
