In the Pipeline
In the Pipeline
September 2008
Anti-Inflammatory Trial Starts Enrolling Patients
Posted 9/24/08
Enrollment has begun in a Phase III registration trial for an analgesic and anti-inflammatory topical cream. The product contains 10 percent ketoprofen, a nonsteroidal anti-inflammatory drug. It is used to treat acute pain in musculoskeletal conditions.
The trial will be conducted with 350 patients at 25–35 sites in the U.S. and possibly in Canada. Trial results will be available in the second half of next year.
Fibromyalgia Treatment Trial Complete
Posted 9/23/08
The first Phase III pivotal clinical trial studying JZP-6 for the treatment of fibromyalgia has been completed. The program includes two randomized, double-blind, placebo-controlled studies. The first one enrolled 550 patients at 65 centers in the U.S.; the second study is enrolling patients at sites in the U.S. and Europe.
The company developing the drug said it remains blinded to the trial results but will release its primary efficacy and safety data in the fourth quarter of the year. It plans to submit a New Drug Application to the FDA by the end of 2009.
Osteoporosis Drug to Move Forward Despite Concerns
Posted 9/11/08
Although the new selective estrogen receptor modulator Fablyn was associated with a significant increase in all-cause mortality when compared with placebo in one arm of a Phase III trial, it still received a green light from an FDA advisory panel . The 8,556-patient trial included 2,852 subjects in each of three different treatment groups — one placebo group, one 0.25-mg dosing arm and one 0.5-mg dosing arm. There were 90 deaths in the 0.25-mg arm, 72 deaths in the 0.5-mg arm and 65 deaths in the placebo arm, the FDA says. All-cause mortality in the 0.5-mg arm did not reach statistical significance.
Despite these safety concerns, an FDA advisory committee voted 9-3 in favor of approving the drug because it could benefit women with a high risk of fractures.
Drug Reduces Incidence of Gout Flares
Posted 9/11/08
Arcalyst reduced the incidence of gout flares in a Phase II study of gout patients initiating therapy with allopurinol to lower their uric acid levels. In the 83-patient, double-blind, placebo-controlled study, the mean number of flares per patient over the first 12 weeks was 0.79 with placebo and 0.15 with arcalyst, an 81 percent reduction.
