Stay up to date on the latest arthritis drugs being developed by pharmaceutical companies and/or reviewed by the Food and Drug Administration (FDA).
May 2007
Second Phase III Trial of Lupus Drug
Posted 5/31/2007
Dosing has begun in Asia, South America and Eastern Europe for BLISS-52, the second of two Phase III clinical trials of belimumab in patients with active systemic lupus erythematosus (SLE). Dosing in BLISS-76, the first Phase III trial of belimumab, began in February in North America and Europe.
Belimumab (LymphoStat-B) has received a fast-track product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA’s continuous marketing application Pilot 2 program.
Calcitonin for Osteoarthritis
Posted 5/29/2007
A Phase III clinical trial of oral calcitonin for the treatment of osteoarthritis has begun. The oral calcitonin product is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis. A new delivery technology creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time. Salmon calcitonin is currently available as a nasal spray for the treatment of osteoporosis.
Enrollment and Initial Dosing Complete for TgAAC94
Posted 5/29/2007
The ongoing Phase I/II clinical trial of tgAAC94 has enrolled its target of 120 participants. The study is designed to assess the safety and potential efficacy of different doses of tgAAC94 administered directly to affected joints of patients with inflammatory arthritis. tgAAC94 is a gene therapy created to inhibit the activity of tumor necrosis factor-alpha (TNF-alpha) directly within inflamed joints rather than systemically.
Fibromyalgia Studies Nearing Completion
Posted 5/24/2007
Top-line Phase III results of the therapeutic effects of milnacipran for the treatment of fibromyalgia syndrome have been released. Participants who received the new medication showed statistically significant improvement in both pain and overall self-assessment of their condition.
Milnacipran is a new class of agent known as norepinephrine serotonin reuptake inhibitors that preferentially inhibit the reuptake of norepinephrine over serotonin, two neurotransmitters known to play essential roles an essential role in regulating pain and mood.
A new drug application that includes data from this study and the first Phase III study for milnacipran are expected to be submitted around the end of 2007.
New Antibody-Derived Drug for RA
Posted 5/24/2007
A Phase I trial of PN0621, which is intended to treat inflammatory diseases such as rheumatoid arthritis, has begun. The trial marks the first administration to humans of a domain antibody-derived product. PN0621 is an anti-TNF domain antibody; it is smaller than conventional antibodies, but retain their important property of participating in highly specific interactions. Domain antibodies cost less to manufacture than full-sized, conventional antibodies, indicating that the end-user price should also be less.
The trial is expected to last for up to four months and will involve 30 healthy volunteers. Participants will each be given a single dose of PN0621 by one of two routes: injection into a vein or under the skin. Final results, after data analysis and review, should be available in late 2007.
One Yearly Treatment for Osteoporosis
Posted 5/11/07
A Phase III trial of zoledronic acid (Reclast) shows a significant reduction in the incidence of all types of osteoporotic bone fractures over three years in women with postmenopausal osteoporosis. Zoledronic acid is a bisphosphonate that is given as a once-yearly intravenous infusion. All currently marketed bisphosphonates are taken orally, either daily, weekly or monthly.
Inhaled Pain Medication
Posted 5/11/07
A Phase IIb trial of inhaled fentanyl (AeroLEF) shows positive results for patients with postoperative pain following orthopedic surgery. This opoid analgesic is being developed as a noninvasive delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
Once-Daily Tramadol Approvable
Posted 5/11/07
The FDA has given CIP-Tramadol ER, a once-daily formulation of tramadol (an opioid analgesic) and approvable letter. This means that, once certain issues have been resolved, the application can be approved and the drug brought to market.
Application Filed for Humira Use in JA
Posted 5/11/07
An application has been filed with the FDA to market adalimumab (Humira) for the treatment of juvenile rheumatoid arthritis. The filing is based on results from a Phase III, pediatric clinical study.
New RA Drug Entering Phase II
Posted 5/11/07
A Phase II study of a new immunotherapy drug for rheumatoid arthritis (RA) has begun enrolling patients. The study will examine the safety and efficacy of MM-093, a recombinant version of human alpha-fetoprotein, in 90 to 100 people with moderate to severe RA who already take methotrexate.
New Drug for Preventing Osteoporosis
Posted 5/11/07
The FDA has issued an approval letter for bazedoxifene, a selective estrogen receptor modulator for the prevention of postmenopausal osteoporosis. Before the FDA will approve the new drug application, it must receive and analyze final safety and efficacy data from the recently completed Phase III study of bazedoxifene.
