The trial was designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre-hydrated and non-hydrated (dry) implants and evaluated the suppression of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5ng/mL on entry into the study, indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH at this level in 94% of patients. Glenn Cooper, chairman and CEO of Indevus, said: "I am extremely pleased to report the successful completion of our octreotide implant trial and we are looking forward to the initiation of our Phase III program in the first half of 2008. The market opportunity for a six-month octreotide implant for the treatment of acromegaly is substantial. The results of the trial demonstrate the potential of our octreotide implant, the only once every six-month treatment, to improve the treatment options for people who suffer from this life-long debilitating condition."