December 2007
Regulatory Update for Viviant
Posted 12/19/07
Reports from two recently completed Asian studies of bazedoxifene (Viviant) have been submitted to the FDA. The data supplement a pending new drug application (NDA) for bazedoxifene for the treatment of postmenopausal osteoporosis as well as the complete response to the safety and efficacy issues raised in the FDA’s April 23 approvable letter for this application. The action date for the application is set for the end of December.
Oral R788 for RA
Posted 12/19/07
Oral R788 has demonstrated statistically significant results in treating rheumatoid arthritis (RA) in a Phase II trial. The multicenter, randomized, double-blind, placebo-controlled, study divided 189 patients into three groups. Each group received 50, 100 or 150 mg of R788 (tamatinib fosdium) twice daily. Groups treated with the drug at 100 and 150 mg showed higher response rates than the placebo group.
Naproxcinod’s Phase III Results
Posted 12/19/07
A Phase III study for naproxcinod, a treatment for treating the signs and symptoms of osteoarthritis, has enrolled 1,020 participants. In the previous study, naproxcinod met all three primary efficacy endpoints and demonstrated a similar effect on systolic blood pressure as placebo and a similar inflammation reduction compared with naproxen, a commonly used anti-inflammatory.
The company anticipates filing of a new drug application for naproxcinod with the FDA in mid-2009.
