Pharmaceutical Business review

Ambrilia reports positive octreotide Phase III results

The primary objective of this study comparing C2L to Sandostatin LAR was met with both C2L and Sandostatin LAR inducing a highly statistically significant decrease of insulin-like growth factor 1 (IGF-1) (p less than 0.005 for both arms) and growth hormone (GH) (p less than 0.0001 for both arms) plasma levels. It was not possible to demonstrate non-inferiority, nor inferiority, of C2L over Sandostatin LAR.

C2L and Sandostatin both induced a statistically significant decrease of IGF-1 and GH plasma levels, at all time points throughout the study and at day 84. The mean percentage of GH decrease was similar in both groups throughout the study. IGF-1 response was also similar, though more pronounced in the Sandostatin group on day 84.