For Chronic Sialorrhea in adults

MY EVIDENCE.

MY CHOICE.

MYOBLOC.

For Chronic Sialorrhea in adults

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Backed by clinical studies, MYOBLOC® is the first and only FDA-approved botulinum toxin B for the treatment of chronic sialorrhea in adults. See why physicians consider MYOBLOC for their patients.

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Sialorrhea can be a challenging symptom of Parkinson’s disease (PD)

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Affecting up to 80% of patients with PD, sialorrhea can be both underrecognized and undertreated.1,2

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Sialorrhea can cause life-threatening complications.*,3-5 

Aspiration pneumonia carries ~20% mortality in patients with PD.6-8

Sialorrhea can affect patients by causing3,5,9-11:

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Speech disturbances

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Sleep disruption

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Social stigma

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Caregiver burden

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Depression

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Skin infection

*There are no studies showing that treating sialorrhea affects specific outcomes on this page.

“I’ll be reading...next thing I know, I’ve got drool all over the place. You’ll get a napkin or paper towel to wipe it off...in 15 minutes it may be the same thing again.” 

George,† living with PD

“It was bad, it was really bad. I could follow him in the house…he was drooling all the way to wherever he was going. He didn’t even realize it.” 

Margaret,† PD caregiver

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Are your patients with PD aware that chronic sialorrhea is a separate and treatable condition?

†Actual patient and caregiver testimonials.

MYOBLOC has a distinct mechanism of action12

Graphic showing the mechanism of action stages for MYOBLOC in chronic sialorrhea

Stage 1: MYOBLOC binds to receptors on the neuronal surface via the heavy chain. 

Stage 2: MYOBLOC enters the nerve cell via endocytosis and is contained in vesicles. 

Stage 3: MYOBLOC light chain moves to the cytosol where it cleaves synaptic vesicle-associated membrane protein (VAMP)* essential for acetylcholine (ACh) release. 

*VAMP is a component of the protein complex responsible for docking and fusion of the synaptic vesicle to the presynaptic membrane, a necessary step in neurotransmitter release. 

For chronic sialorrhea, blocking ACh release from the neurosecretory cells of the salivary glands reduces saliva production.12

Graphic showing the mechanism of action stages for MYOBLOC in chronic sialorrhea
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Proven clinical efficacy and tolerability for chronic sialorrhea

SELECT A DATA SET
  • A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    • 187 adult patients enrolled
    • Objectives: Determine efficacy, safety, and tolerability over a 13-week period
    • Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
    • Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
  • A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    • 187 adult patients enrolled
    • Objectives: Determine efficacy, safety, and tolerability over a 13-week period
    • Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
    • Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
  • A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    A phase 3, multicenter, randomized, double-blind, placebo-controlled, single-treatment efficacy and safety study

    • 187 adult patients enrolled
    • Objectives: Determine efficacy, safety, and tolerability over a 13-week period
    • Unstimulated Salivary Flow Rate (uSFR) and Clinical Global Impression of Change* (CGI-C) at Week 4: Primary endpoints
    • Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C), Drooling Impact Score (DIS), Drooling Frequency and Severity Scale (DFSS): Secondary endpoints
  • A phase 2, multicenter, double-blind, placebo-controlled, sequential dose-escalation study

    A phase 2, multicenter, double-blind, placebo-controlled, sequential dose-escalation study

    • 54 adult patients enrolled
    • 4 dose arms: 1,500 Units (n=14); 2,500 Units (n=12); or 3,500 Units (n=13) vs. matching placebo (n=15)
    • Patients were followed for up to 20 weeks after injection
    • Primary outcome measures: Safety and tolerability
    • All efficacy measures were considered secondary
      • uSFR and CGI-C were measured at Week 4 and other selected time points

Significant improvement in uSFR was demonstrated at Week 4 for all doses tested11-13

Primary endpoint

Study 1 (Part A)
At Week 4, MYOBLOC 2,500 U and 3,500 U achieved:
Graphic showing 56%
REDUCTION IN uSFR

from baseline vs. 11% with placebo

(-0.37 and -0.36 vs. -0.07, respectively, P<0.0001)

Early, significant, and enduring effect11-13

Secondary endpoints

Study 1 (Part A)
MYOBLOC treatment resulted in a significantly greater reduction in uSFR vs. placebo
Chart showing comparing reductions in unstimulated salivary flow rate over 13 weeks for MYOBLOC and placebo Chart showing comparing reductions in unstimulated salivary flow rate over 13 weeks for MYOBLOC and placebo
  • Reductions began at Week 1 and continued through Week 8 for both doses tested
  • Significant effect continued through Week 13 for the 3,500 Unit dose
In the Phase 3, open-label extension (Study 1, Part B), improvement in uSFR was maintained for over 1 year with subsequent dosing of MYOBLOC 3,500 U.†

†Limitations associated with open-label study design, include lack of comparator arm, decreasing sample size and potential continued involvement of responders and attrition of nonresponders.

Calculating uSFR12,14:

  1. Weigh empty collection cup
  2. Have patient clear any saliva in mouth
  3. Start 5-minute timer
  4. Instruct patient to allow saliva to pool in floor of mouth and expectorate into cup
  5. At 5 minutes, have patient expectorate any remaining saliva
  6. Weigh cup filled with saliva

uSFR = (ending weight – starting weight) / 5 minutes

Abbreviation: uSFR, Unstimulated Salivary Flow Rate.

Significant improvement in CGI-C was demonstrated at Week 4 for all doses tested11-13

Primary endpoint

Study 1 (Part A)
At Week 4, MYOBLOC 2,500 U and 3,500 U achieved:
Graphic comparing improvements at week 4 of Clinical Global Impression of Change for MYOBLOC and placebo Graphic comparing improvements at week 4 of Clinical Global Impression of Change for MYOBLOC and placebo

*Chronic sialorrhea was "much improved" or "very much improved" according to CGI-C score at Week 4 post-injection in patients treated with MYOBLOC 2,500 Units (60%) and 3,500 Units (53%) compared to patients on placebo (12%).

In the Phase 3, open-label extension (Study 1, Part B), improvement in CGI-C was maintained for over 1 year with subsequent dosing of MYOBLOC 3,500 U.†

†Limitations associated with open-label study design, include lack of comparator arm, decreasing sample size and potential continued involvement of responders and attrition of nonresponders.

Assessing CGI-C12,14:

The blinded assessor (other than the physician who injects the study drug) will rate their impression of change in the patient's symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The CGI-C is a 7-point scale ranging from a score of 1, “very much improved,” to a score of 7, “very much worse.”

Abbreviation: CGI-C, Clinical Global Impression of Change.

MYOBLOC has demonstrated tolerability11-13

Studies 1 and 2

Adverse reactions in at least 5% of MYOBLOC-treated patients and greater than placebo in pooled chronic sialorrhea studies

Table showing adverse reactions in at least 5% of MYOBLOC-treated patients and greater than placebo in pooled chronic sialorrhea studies

*Adverse reactions for 1,500 Unit dose were only evaluated in Study 2.

†Adverse reactions for 2,500 Unit and 3.500 Unit doses were evaluated in Studies 1 and 2.

Graphic showing the number of patients who discontinued due to dry mouth Graphic showing the number of patients who discontinued due to dry mouth

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