SKYEPHARMA RELEASES POSITIVE RESULTS FOR RA TREATMENT TRIAL

SkyePharma has announced positive results of a Phase III clinical trial of Lodotra, a new, modified-release tablet that has been developed in partnership with Nitec Pharma to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis (RA). Lodotra uses SkyePharma's proprietary GEOCLOCK technology and was filed with regulatory authorities in August by Nitec.

Lodotra provides all the benefits of standard immediate-release (IR) prednisone but has the additional advantage of significantly reducing morning symptoms combined with a convenient dosing regimen. The diurnal rhythm in RA is characterized by elevated nighttime levels of inflammatory cytokines such as IL6, which leads to extreme stiffness and pain in the hours immediately after waking. It has been established that these morning symptoms can be addressed with prednisone administered at 2 a.m. However, until now this has been impossible without disturbing sleep. Lodotra is an oral medication that has a unique delivery system ensuring rapid release of the prednisone from the tablet core about 4 hours after ingestion. Administration of Lodotra at bedtime results in a release of prednisone at about 2 a.m. for a more effective treatment of the morning symptoms of RA.

The trial involved 288 patients in 26 centers in Europe, and was a randomized, double-blind, active-controlled, parallel-group Phase III study. The study compared the efficacy and safety of Lodotra given to patients before sleep the evening before, with standard IR prednisone over a period of 12 weeks. The duration of morning stiffness (the primary clinical endpoint of the study) was significantly reduced in the Lodotra group while under standard IR prednisone no change in morning stiffness was shown. Lodotra was also shown to be well-tolerated and just as safe as the standard regimen. Importantly, IL6 levels were shown to be reduced in the Lodotra group but remained constant in the standard prednisone group.