09 Jul FDA Approves MYCAPSSA® (Oral Octreotide) for Treatment of Growth Disorder Acromegaly
MedicalResearch.com Interview with:
Dr. Samson
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.
MedicalResearch.com: What are the main findings of the Phase 3 study?
Response: Study participants maintained a biochemical response at 36 weeks achieved with previous injection therapy with no serious adverse events. Specifically, results from the Phase 3 study demonstrated that 58% (16/28) of patients on MYCAPSSA maintained their IGF-1 control compared to 19% of patients on placebo after nine months (p=0.008, as measured using the average of the last two IGF-I levels ≤ 1.0 × upper limit of normal at weeks 34 and 36).
MedicalResearch.com: What should readers take away from your report?
Response: Now, that MYCAPSSA has been approved by the U.S. Food and Drug Administration (FDA), patients with acromegaly are able to take a convenient pill from home that has been proven to be effective. I have witnessed firsthand the burdens that injections create for my patients, as they often have to miss work or other important obligations. No other oral somatostatin receptor ligand therapy has been approved
for patients with acromegaly and MYCAPSSA addresses a significant unmet need.
Disclosures: Chiasma funded the Phase 3 CHIASMA OPTIMAL (Octreotide capsules vs. Placebo Treatment In MultinationAL centers) study. Dr. Samson has served as an advisory board member for Chiasma and Novartis, received grants from Novartis and served as a research investigator for Chiasma, Corcept, Novartis and OPKO.
Citation: ENDO 2020 abstract
Samson SL, Nachtigall LB, Fleseriu M, et al. OR23-07 Results From the Phase 3, Randomized, Double-Blind, Placebo-Controlled CHIASMA OPTIMAL Study of Oral Octreotide Capsules in Adult Patients with Acromegaly. J Endocr Soc. 2020;4(Suppl 1):OR23-07. Published 2020 May 8. doi:10.1210/jendso/bvaa046.211
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Last Updated on July 9, 2020 by Marie Benz MD FAAD