MYCAPSSA Delivers the Efficacy of Octreotide

MYCAPSSA Is an Extensively Studied Oral Treatment

The safety and efficacy of MYCAPSSA were studied in 3 clinical trials.^1-4

329* people living with acromegaly, who responded to and tolerated injectable somatostatin analog (SSA) treatment with octreotide or lanreotide, participated in the trials.

Study	Treatments studied	Number of participants	Outcome
Phase 3 Open-Label Study	MYCAPSSA	N=155	Assessed efficacy and safety profiles of MYCAPSSA
OPTIMAL	MYCAPSSA vs placebo	N=56	Established efficacy and safety profiles of MYCAPSSA Led to the FDA approval of MYCAPSSA
MPOWERED	MYCAPSSA vs injectable SSA	N=146	Demonstrated that MYCAPSSA maintained biochemical control^†

Study

Phase 3

Open-Label Study

Treatments studied

MYCAPSSA

Number of participants

N=155

Outcome

Assessed efficacy and safety profiles of MYCAPSSA

Study

OPTIMAL

Treatments studied

MYCAPSSA vs placebo

Number of participants

N=56

Outcome

Established efficacy and safety profiles of MYCAPSSA
Led to the FDA approval of MYCAPSSA

Study

MPOWERED

Treatments studied

MYCAPSSA vs injectable SSA

Number of participants

N=146

Outcome

Demonstrated that MYCAPSSA maintained biochemical control^†

The MPOWERED study was not powered to report noninferiority or superiority between arms for symptoms and patient-reported outcomes. Patients who enrolled did so with the understanding that they may receive MYCAPSSA. The enrolled population may have been enriched for those who were unsatisfied with injectable therapy.

FDA, US Food and Drug Administration; IGF-I, insulin-like growth factor 1; ULN, upper limit of normal.

^*Twenty-eight patients in OPTIMAL received placebo.

^†Primary endpoint of noninferiority assessment of the proportion of patients maintaining biochemical response (IGF-I <1.3 × ULN using time-weighted average) throughout the randomized controlled treatment phase.

The Biochemical Control You Expect of Octreotide

In the OPTIMAL Trial¹:

~60% of patients on MYCAPSSA maintained IGF-I response^‡ vs ~20% of patients on placebo
Mean IGF-I levels in patients on MYCAPSSA were maintained within the normal range

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

In the MPOWERED Trial²:

The primary endpoint of noninferiority to iSSA was met
91% of MYCAPSSA-treated patients maintained biochemical control^§ vs 100% of those treated with an iSSA

Biochemical Responders at 15 Months

MPOWERED Open-Label Extension⁵:

Patients who completed the MPOWERED core trial were invited to participate in the open-label extension phase
All participants received MYCAPSSA regardless of their prior randomized controlled treatment assignment

Proportion of Biochemical Responders  at the End of Each Year^5||

iSSA, injectable somatostatin analog; ULN, upper limit of normal.
95% confidence intervals (CI) represent number of patients.
^‡IGF-I response was defined as an average of weeks 34 and 36 IGF-I ≤1.0 × ULN (P = .008). 58% of patients on MYCAPSSA maintained IGF-I response vs 19% of patients on placebo.
^§Data are representative of patients responding to both iSSAs and MYCAPSSA. Biochemical response was defined as IGF <1.3 x ULN using time-weighted average.
^||A patient was considered a responder at the beginning or end of the year if their IGF-I was <1.3 × ULN. Patients who entered a year as a responder and had an end-of-year response were included in the year’s analysis.

Control of Common and Breakthrough Symptoms

Fewer Patients Have Reported Breakthrough Symptoms:

Breakthrough symptoms were defined as any worsening of symptoms prior to the next scheduled dose of medication for the treatment of acromegaly.^2,6

In the MPOWERED Trial¹:

In patients previously treated with iSSAs, fewer MYCAPSSA-treated patients reported breakthrough symptoms at the end of the run-in phase vs baseline.

Reported Breakthrough Symptoms

Across Multiple Trials, MYCAPSSA-Treated Patients Demonstrated Consistent Symptom Control^2,4,7

Open-Label Trial^¶

MPOWERED Trial^#

^¶Proportion of patients with active individual symptoms from baseline to end of treatment. Fixed-dose population (n = 110). For patients not completing the core treatment period, the last assessment during the core treatment period was used. For patients not completing the extension treatment period, the last assessment during the extension treatment period was used.
^#Proportion of patients with active individual symptoms at indicated timepoint during run-in phase.

Patients reported long-term symptom control in the
MPOWERED Open-Label Extension.⁵

Watch Bonnie as she talks about her experience with breakthrough symptoms.

MYCAPSSA Has a Well-Established Safety Profile

A Safety Profile Consistent With Octreotide, Without Injection-Related Reactions⁴

In clinical studies, MYCAPSSA was shown to be generally well tolerated^1,3

GI-related adverse events were mostly transient and resolved in less than 2 weeks.⁴ Across 2 phase 3 trials, GI-related AEs were:

Reported in 57% and 68% of patients
Mostly mild to moderate and occurred during the initial 3 months of treatment

AE, adverse event; GI, gastrointestinal.

+35years

The MYCAPSSA safety profile is supported by more than 3 decades of real-world clinical experience with octreotide.³

Treatment-related and treatment-emergent AEs occurring in ≥5% of patients in either treatment group during the randomized phase by system organ class and preferred term^‡‡

MYCAPSSA Safety Proﬁle Compared to Placebo³

Adverse Event Data in Patients Who Responded to MYCAPSSA and to iSSAs^2††

Treatment-related and treatment-emergent AEs occurring in ≥5% of patients in either treatment group during the randomized phase by system organ class and preferred term^‡‡

^**Includes blood glucose increased, hyperglycemia, and glycosylated hemoglobin increased.
^††Data are representative of patients responding to both iSSAs and MYCAPSSA.
^‡‡An adverse event was considered related if the relationship to study drug was reported as possibly related or related.

For Patients With Renal or Hepatic Impairment³

Acromegaly is associated with a higher risk for end-stage renal disease and hepatomegaly^8-10

Patients with end-stage renal disease may initiate MYCAPSSA at a lower 20-mg dose³

No dose adjustment is necessary for patients with mild, moderate, or severe renal impairment or for patients with hepatic impairment³

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Important Safety Information

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 B₁₂ levels 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.

New onset of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur with MYCAPSSA and other somatostatin analogs. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency and manage accordingly.

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.

Please report adverse events to Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including Medication Guide.

Important Safety Information

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

Adverse Reactions

Drug Interactions

Pregnancy

MYCAPSSA Delivers the Efficacy of Octreotide

MYCAPSSA Is an Extensively Studied Oral Treatment

Important Safety Information

Indication

Important Safety Information

Indication