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# FDA, Chiasma Reach Agreement on SPA
- URL: https://www.fdaweb.com/fda-chiasma-reach-agreement-on-spa/
- Published: 2017-08-11T12:00:00.000Z
- Updated: 2026-09-14T22:40:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139363

FDA and Chiasma have reached agreement on a special protocol assessment on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The study is designed to address agency concerns raised in a previously issued [complete response letter](https://www.globenewswire.com/Tracker?data=6wBDX5OHLizex4tV2zQLXnjURu7aQp0xg2GUL8a7XmYgjNWUxNbsSJ%5F605rE2xNlmpxUP7FWp77khWBgAPa06XhZvYrc%5F0FouzMEO8fhIkJdy5ajU0w10nO3KNEVRuIioDnKJ3rZXQwD6lJtniz5U6xLxC9T33nLK%5FhODZtmYUU=&ref=fdaweb.com).

  
The OPTIMAL (Octreotide Capsules vs. Placebo Treatment In Multinational Centers) is a randomized, double-blind, placebo-controlled, nine-month trial in 50 adult acromegaly patients (at least 20% of whom must be recruited from the U.S.), according to the company. Chiasma believes the “trial is adequately powered to assess maintenance of biochemical control with octreotide capsules compared to placebo in adult acromegaly patients who previously demonstrated biochemical control on somatostatin receptor ligand injections.” It expects top-line trial data by the end of 2019.