MedicalResearch.com Interview with:
Susan Leanne Samson, M.D., Ph.D., FRCPC, FACE
Associate Professor (tenured)
Department of Medicine
Endocrinology, Diabetes and Metabolism
Medical Director,Pituitary Center
Program Director
,Endocrinology Fellowship
Baylor College of Medicine
Dr. Samson discusses the FDA approval of MYCAPSSA
® (octreotide) capsules as the
first and only oral somatostatin analog (SSA) for the long-term maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Acromegaly? How do octreotide or lanreotide impact this disease? What is unique about MYCAPSSA?
Response: The Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) study was a randomized, double-blind, placebo-controlled trial designed to evaluate the biochemical response of patients with acromegaly to MYCAPSSA® compared to placebo. This pivotal study included 56 adults, 28 patients in each arm, and met its primary endpoint and all four secondary endpoints.
Acromegaly is a rare disorder typically caused by a noncancerous tumor of the pituitary gland, which is located just below the brain. This tumor produces too much growth hormone (GH), which causes the liver to overproduce another hormone called insulin-like growth factor 1 (IGF-1). Excess GH or IGF-1 in the bloodstream results in growth in the tissues of the body and causes a wide range of symptoms. If untreated, acromegaly may alter facial appearance, cause enlargement of the hands, feet, and organs, cause joint pain and lead to other life-altering complications, including diabetes, elevated blood pressure, and cardiovascular disease.
After surgery, octreotide and lanreotide long-acting injections are often the first choice for the treatment of acromegaly. Both of these medications mimic the effects of somatostatin, a naturally occurring hormone that reduces the secretion of GH by binding to GH receptors on the surface of specialized cells in the pituitary gland. For GH secreting pituitary tumors, these medications can reduce GH and IGF-1 levels, and even cause the tumor to shrink. However, injections also carry significant treatment and emotional burdens including pain and other injection-site reactions, suboptimal symptom control and worsened quality of life due to loss of independence.
MYCAPSSA contains octreotide but is the first and only oral somatostatin receptor ligand indicated for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA provides the known benefits of octreotide but eliminates many of the treatment burdens associated with injectable delivery and can be taken from the comfort of home.
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