The Food and Drug Administration (FDA) has approved Mycapssa® (octreotide; Chiasma) capsules for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
Mycapssa, an oral somatostatin analogue, utilizes a proprietary technology (Transient Permeability Enhancer®), which allows for the development of oral formulations of drugs previously only available as injectables. The delayed-release capsules should be taken on an empty stomach as administration of Mycapssa with food led to an approximate 90% decrease in the rate and extent of absorption, according to pharmacokinetic data.
The approval was based on data from the 9-month, double-blind, placebo-controlled phase 3 CHIASMA OPTIMAL trial that evaluated the efficacy and safety of Mycapssa in 56 adults with acromegaly whose disease was biochemically controlled by injectable somatostatin analogues (octreotide or lanreotide) based upon levels of insulin-like growth factor 1 (IGF-1). Eligible patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥1.3 × upper limit of normal (ULN).
Patients were randomized 1:1 to receive either Mycapssa capsules or placebo. The primary end point was the proportion of patients who maintained their biochemical response at week 36, as measured using the average of the last 2 IGF-1 levels ≤1.0 × ULN assessed at weeks 34 and 36.
Results showed that a greater proportion of patients in the Mycapssa treatment arm had maintained their biochemical response at week 36 compared with placebo (58% vs 19%). Among those treated with Mycapssa, 25% required discontinuation and treatment with other somatostatin analogues at some point during the study.
“Results from the pivotal phase 3 CHIASMA OPTIMAL clinical trial are encouraging for patients with acromegaly,” said Susan Samson, MD, PhD, FRCPC, FACE, principal investigator of the CHIASMA OPTIMAL clinical trial. “Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need.”
Regarding safety, the most common adverse reactions observed with Mycapssa included nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, increased blood glucose, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.
The Company expects to launch Mycapssa in the fourth quarter of 2020. The product will be available as 20mg delayed-release capsules of octreotide in 28-count wallets.
For more information visit mycapssa.com.