EFFICACY & SAFETY

EFFICACY

MYCAPSSA Efficacy in the Pivotal Phase 3 Trial

Majority of MYCAPSSA-Treated Patients Maintained IGF-I Control^1,2

58% of patients on MYCAPSSA vs 19% of patients on placebo maintained IGF-I response^1,2*

*IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 x upper limit of normal (ULN) (P=0.0079)^1,2

The mean IGF-I level was maintained within normal range in the group receiving MYCAPSSA at the end of oral treatment²

Mean Levels of IGF-I at Baseline vs End of Treatment²

Study Design: The Pivotal Phase 3 Trial²

The Pivotal Phase 3 Trial was a 9-month, randomized, double-blind, placebo-controlled study in 56 patients with acromegaly and IGF-I ≤ 1 x upper limit of normal (ULN) at screening.

Starting dose: 40 mg (20 mg AM + 20 mg PM)

Dose titration was performed during the first 6 months of the study to a dose of 60 mg (40 mg AM + 20 mg PM) and up to a maximum dose of 80 mg daily (40 mg AM + 40 mg PM) based on biochemical results or symptoms.

Patients then maintained a fixed dose until end of treatment.

Primary Endpoint

Proportion of patients who maintained biochemical response. Response was defined as an average IGF-I≤1.0 x upper limit of normal (ULN) based on average of weeks 34 and 36.

Secondary Endpoints

Proportion of patients who maintained GH response at week 36 (average GH <2.5 ng/mL).

Time to loss of IGF-I response defined as either IGF-I >1.0 or ≥ 1.3 x ULN for 2 consecutive visits.

Proportion of patients who reverted to prior iSSA up to and including week 36 measurements.

SAFETY

MYCAPSSA Safety Profile Compared to Placebo¹

^aIncludes blood glucose increased, hyperglycemia, and glycosylated hemoglobin increased.

GI-related AEs resolved within a median duration of 2 weeks after onset.

GI AEs were reported in up to 68% of MYCAPSSA patients.¹

GI AEs were mostly mild to moderate.

AEs occurred mostly during the initial 3 months of treatment and resolved on treatment within a median duration of less than 2 weeks after onset.¹

AEs, adverse events; GI, gastrointestinal.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE
MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

CONTRAINDICATIONS
Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B₁₂levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

ADVERSE REACTIONS
The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

DRUG INTERACTIONS
The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women taking an oral contraceptive to use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

PREGNANCY
Advise premenopausal females of the potential for an unintended pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch