Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Octreotide capsule is a novel, orally-administered formulation of the commercially-available
 injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated
 maintenance of biochemical response up to 13 months in the majority of patients with
 acromegaly previously managed with somatostatin analog injections (reference below).
This is a double blind, randomized study that assesses the efficacy and safety of octreotide
 capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin
 analogs, who are biochemically controlled and have prior evidence of active disease, will be
 randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of
 this double blind, placebo controlled period, eligible patients will receive octreotide
 capsules in an open-labeled extension for at least one year. Patients failing to respond (per
 protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with
 the standard of care and upon meeting the eligibility criteria could also enroll into the
 long term extension with octreotide capsules.

 This study received agreement from the FDA, under a special protocol assessment.
Inclusion Criteria:

 -  Documented evidence of active acromegaly

 -  Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
 6 months with a stable dose for at least the last three months of therapy

 -  Biochemically controlled

 Exclusion Criteria:

 -  Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as
 indicated in the label

 -  Pituitary surgery within six months

 -  Conventional or stereotactic pituitary radiotherapy any time in the past

 -  Patients who previously participated in CH-ACM-01 or OOC-ACM-302

 -  Any clinically significant uncontrolled concomitant disease

 -  Symptomatic cholelithiasis

 -  Pegvisomant, within 24 weeks

 -  Dopamine agonists, within 12 weeks

 -  Pasireotide, within 24 weeks