Chiasma announced that it has submitted a New Drug Application (NDA) to the FDA for octreotide capsules for the maintenance treatment of adults with acromegaly.
The NDA submission is based on a multicenter Phase 3 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 seven-month core treatment phase and an optional six-month extension phase. The primary endpoint was met with 65% of patients in the modified intent to treat (mITT) population who received octreotide capsules twice-a-day who were classified as responders, at the end of the seven-month core treatment period. Sixty-two percent of patients in the mITT population were classified as responders at the end of the six-month extension phase.
For more information visit ChiasmaPharma.com.