SkyePharma announces completion of Sular trial

SkyePharma and Sciele Pharma have announced the successful completion of a clinical trial programme for a new formulation of Sular (nisoldipine). The results showed that this novel formulation of the compound is bioequivalent to the existing form of Sular currently marketed by Sciele.

This new formulation of the calcium blocking agent used as a treatment for patients with high blood pressure uses the Geomatrix technology from SkyePharma and aims to facilitate the use of smaller doses of the compound in treatments given to patients.

Sular is an antihypertensive drug that relaxes the muscles of smaller arteries to facilitate their dilation without affecting the muscles themselves or veins in the heart. The compound operates by preventing calcium – necessary for muscle contractions – entering the specific muscle cells.

“The data from this study will be combined with the results from the previous clinical trial in Sciele’s new Sular formulation supplemental New Drug Application (sNDA) filing. Sciele expects to file an sNDA with the US Food and Drug Administration by end of the second quarter of 2007,” Skye Pharma reports.

SkyePharma notes that at present, half of those receiving treatment for high blood pressure attain set treatment goals, suggesting that there exists scope for the development of improved therapies for the condition.

In May 2006, the company signed an agreement with First Horizon Pharmaceutical – the predecessor of Sciele – for the development of a controlled-release formulation of Sular with an improved pharmacokinetic profile.