MYCAPSSA® is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is typically caused by a benign tumor of the pituitary gland that releases excess growth hormone (GH), leading to excess growth of certain parts of the body.
How Octreotide Capsules are Designed to Work
Octreotide capsules are designed to exhibit the effects of somatostatin, a naturally occurring hormone that reduces the production of GH by binding to receptors on specialized cells in the pituitary gland.
Because octreotide capsules were developed using our Transient Permeability Enhancer (TPE®) technology, they can be administered orally and absorbed into the bloodstream. This means octreotide capsules have the potential to serve as an alternative to the current standard-of-care injection therapy that is available for people living with acromegaly today. There are currently no approved oral formulations of octreotide.
The following scientific resources provide additional information about the potential of octreotide capsules for the maintenance treatment of acromegaly.
- Melmed S, al. “Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial.” The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 4, 1 April 2015, Pages 1699–1708, https://doi.org/10.1210/jc.2014-4113
- Tuvia S, et. Al. “A Novel Suspension Formulation Enhances Intestinal Absorption of Macromolecules Via Transient and Reversible Transport Mechanisms.” Pharmaceutical Research, Volume 31, issue 8, 21 February 2014, Pages 2010–2021, https://doi.org/10.1007/s11095-014-1303-9
Octreotide capsules, also known as MYCAPSSA®, have only been approved by the United States Food and Drug Administration (FDA) for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Other than the foregoing FDA approval, octreotide capsules are an investigational product and have not been approved by the FDA for other indications or by the European Medicines Agency or any other regulatory agency.