Octreolin (octreotide oral) filed with FDA for acromegaly- Chiasma

Chiasma has submitted a New Drug Application to the FDA seeking approval for the marketing and sale of octreotide capsules, an investigational drug for the maintenance treatment of adults with acromegaly. The application is supported by a multicenter Phase III study, which evaluated patients for biochemical and symptomatic disease control over a period of up to 13 months following treatment with octreotide capsules, comprised of a 7-month core treatment phase and an optional 6-month extension phase.

Sixty-five percent of patients in the modified intent to treat (mITT) population who received octreotide capsules twice-a-day were classified as responders, as measured by circulating concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH), at the end of the 7-month core treatment period, the primary endpoint of the trial. Sixty-two percent of patients in the mITT population were classified as responders at the end of the 6-month extension phase. In the study, the severity and incidence of acromegaly symptoms improved while on octreotide capsules, compared to baseline. The Phase III results were published in the Journal of Clinical Endocrinology & Metabolism.

omment: If approved, octreotide capsules will be the first oral somatostatin analog approved for acromegaly. Octreotide capsules has been granted orphan designation in the U.S. and the EU for the treatment of acromegaly.