April 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).
April 2007
Enrollment in Phase II Osteoporosis Study Complete
Posted 4/23/07
Enrollment in the STRONG Study, a Phase II clinical trial of NB S101, has been completed. This once-daily tablet containing strontium malonate as its active ingredient is being developed as a treatment for osteoporosis. Patients enrolled into the trial are being treated for 12 weeks; results of the study are expected near the end of 2007.
Paget's Disease Treatment Approved
Posted 4/23/07
The FDA has approved zoledronic acid (Reclast) injection for the treatment of Paget's disease of bone, the second most prevalent bone disease after osteoporosis. It is the first and only single-dose treatment regimen for Paget's disease and the first new treatment for the disease in nearly a decade. Zoledronic acid is given as a single 15-minute intravenous infusion by a healthcare professional. It works by attaching to bone, stopping excessive bone breakdown and rebalancing the body's natural bone remodeling process.
New Dosage of Risedronate Approved
Posted 4/23/07
The FDA has approved a new dose of risedronate sodium (Actonel) that will give patients the option of taking one 75-mg tablet on two consecutive days, for a total of two tablets monthly, to treat and prevent postmenopausal osteoporosis.
Trial Design Approved for SLE Study
Posted 4/11/2007
The design and planned analyses for a Phase III clinical trial of prasterone (Prestara) for the treatment of systemic lupus erythematosus has been approved by the FDA. Prasterone is the synthetic equivalent of DHEA, the most abundant adrenal hormone in humans. DHEA levels are known to be low in people with lupus.
Humira for Psoriasis
Posted 4/9/2007
A supplemental biologics license application has been submitted to the FDA seeking approval to market adalimumab (Humira) as a treatment for moderate to severe chronic plaque psoriasis. The submissions are based on the results of two double-blind, placebo-controlled trials of adalimumab. In both trials, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) score.
New Class of Drugs for OA in the Works
Posted 4/9/2007
Naproxcinod is the first compound in a new class of drugs for the treatment of osteoarthritis: the COX-inhibiting nitric oxide-donating class. Naproxcinod is metabolized to produce naproxen and nitric oxide, which helps control blood pressure by dilating blood vessels. The first of three Phase III studies demonstrated that naproxcinod was superior to placebo and comparable to naproxen in reducing pain and improving function, while controlling blood pressure. The second Phase III trial just began, and is expected to enroll approximately 1,020 patients at 120 clinical centers in the U.S. Efficacy results are expected in mid-2008. Pending completion of the second and third phase III studies, a new drug application will be submitted to the FDA during first quarter 2009.
NSAID With Decreased Ulcer Risk In Phase III
Posted 4/2/2007
A Phase III trial program has begun for HZT-501, a nonsteroidal anti-inflammatory drug (NSAID) for mild-to-moderate pain relief. HZT-501 is a formulation of ibuprofen combined with the H2 receptor antagonist famotidine in a single pill. HZT-501 is specifically designed to provide pain relief while reducing stomach acidity. The two trials in the Phase III clinical program will involve a total of 1,200 patients with mild-to-moderate pain, including patients with osteoarthritis. The studies will evaluate the efficacy and safety of HZT-501 with the primary efficacy endpoint being reduction in the risk of development of ibuprofen-associated upper gastrointestinal ulcers.
CRx-139 for RA Needs More Testing
Posted 4/2/2007
The preliminary results of a Phase II clinical trial of CRx-139 (a combination of 3 mg of prednisolone and the antidepressant paroxetine) and 3 mg of prednisolone alone in patients with rheumatoid arthritis (RA) have been announced. This trial evaluated the effectiveness of two doses of CRx-139 (containing 10 or 20 mg of paroxetine with prednisolone) and 3 mg of prednisolone in subjects with active RA. The primary endpoint was an American College of Rheumatology (ACR)-20 improvement score. Another purpose of the trial was to evaluate the activity of CRx-139 compared with prednisolone alone. CRx-139 did not show statistical significance on the primary endpoint of the trial, but it did show statistical significance on multiple other endpoints, requiring further analysis.
New Treatment for Osteoporosis Being Tested
Posted 4/2/2007
A Phase II clinical trial of BA058, which is being developed for the treatment of osteoporosis in postmenopausal women, has begun enrolling patients. BA058 is an analog of human parathyroid hormone-related protein. Parathyroid hormone-related protein promotes new bone formation, with a role distinct from parathyroid hormone, which regulates calcium homeostasis and bone resorption.
New Crohn’s Disease Medication Also to be Tested in RA
Posted 4/2/2007
Certolizumab pegol (Cimzia) is being tested to confirm its activity in moderate to severe Crohn’s disease. Results from this additional clinical study are expected in the second half of 2008. The developing pharmaceutical company also plans to file a biologics license application with the FDA for Cimzia in the treatment of rheumatoid arthritis by the end of the year.
