Horizon Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Lodotra, for the treatment of rheumatoid arthritis.
Lodotra, which is currently approved for marketing in 16 European countries, is a modified (delayed)-release formulation of low-dose prednisone.
The NDA submission by the company is based on results from Circadian Administration of Prednisone in RA (CAPRA-2), a 12 week double-blind placebo-controlled Phase 3 trial involving 350 RA patients.
Results from CAPRA-2 demonstrated an improvement in American College of Rheumatology 20 (ACR20), ACR50 and ACR70 response criteria for patients who were treated with Lodotra compared to the placebo group.
In addition, data also included results from the 12 week double-blind placebo-controlled CAPRA-1 study evaluating 288 RA patients which showed a reduction in morning stiffness and IL-6 levels of approximately 29%.