Image: Man with girl

MY HOPE:
A proven, effective treatment for my chronic sialorrhea.

All photos on this site are actor portrayals.

MYOBLOC is the only approved botulinum toxin for chronic sialorrhea in adults that can provide significant results in as early as 1 week.1,2


MECHANISM OF ACTION (MOA)

Blocks acetylcholine (ACh) release at the cholinergic neurosecretory junction of the salivary glands1

Illustration of the various stages of MYOBLOC in action

MYOBLOC cleaves synaptic vesicle-associated membrane protein (VAMP)*

  • This blocking action reduces salivaproduction
  • MYOBLOC has been hypothesized toshow a sensitivity to cholinergicautonomic neurons, especiallypostganglionic neurons containing M3receptors3,4

VIEW MOA VIDEO   

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

Group 69

What would symptom relief in as early as 1 week mean
to your patients and their caregivers?

PROVEN CLINICAL EFFICACY AND DEMONSTRATED TOLERABILITY

Click each to see specific data 

#study-1-part-a
Group 5

SIGNIFICANT
IMPROVEMENT
in primary efficacy
measures1,2

#study-1-part-a-contd
Group 10

SIGNIFICANT
symptom relief
as early as

#study-1-part-a-contd
Group 10

DURATION
of action up to

#study-1-part-a-secondary
Group 5

SIGNIFICANT
IMPROVEMENT
in secondary efficacy
measures1,5

#study-1-part-b
Group 11 5

EFFICACY
maintained with
subsequent dosing
of 3,500 Units for
over

#demonstrated-tolerability
Group 8

Demonstrated TOLERABILITY1

CLINICAL STUDIES 1,5

Study 1

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

  • 187 patients enrolled
  • Objectives: Determine efficacy, safety, and tolerability over a 13-week period
  • Primary efficacy measures: Unstimulated Sailvary Flow Rate (USFR) and Clinical Global Impression of Change (CGI-C) at Week 4

DEMONSTRATED EFFICACY1

Study 1: Part A Results

Two bar graphs showing the USFR mean change from baseline at Week 4 and the CGI-C mean score at Week 4

IMPROVEMENT AS EARLY AS 1 WEEK1,5

Study 1: Part A Results (cont’d)

MYOBLOC Treatment Resulted in a Significantly Greater Reduction in USFR vs. Placebo1,5

Line graph comparing USFR over 13 weeks for MYOBLOC 3,500, MYOBLOC 2,500, 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

Study 1: Part A, Secondary Endpoints

2,500 Unit and 3,500 Unit doses significant on all scales at Week 45

Patient's Global Impression of Severity, Patients Global Impression of Change, Drooling Impact Score, Drooling Frequency and Severity Scale

Study 1: Part B

Phase 3, open-label, multiple-treatment extension study (N=170) to assess duration of efficacy, safety, and tolerability over a maximum of 65 weeks. Patients received up to 4 additional treatment sessions over 1 year5

Efficacy was maintained at subsequent
dosing of 3,500 Units for over 1 year5

Study 2

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

  • 54 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

Study 2 Results:
Significant reduction in
USFR and CGI-C at Week
4 for all 3 MYOBLOC
dosage groups compared with placebo1,2

DEMONSTRATED TOLERABILITY1

Studies 1 and 2:

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.

Table comparing adverse reactions across 1,500 units, 2,500 units, 3,500 units and placebo

1 patient discontinued due to dry mouth

Pie chart representing 1 patient who got dry mouth vs 241 who didn't
  • The most common adverse reaction was dry mouth
    • The majority of dry mouth adverse reactions were mild to moderate5
  • The frequency of these common adverse reactions did not appear to be dose-dependent, except in the case of dry mouth

RATING SCALES AND MEASUREMENTS EXPLAINED1,2:

CALCULATING USFR:

  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

Assessing CGI-C:

The blinded assessor (other than the physician who injects the study drug) will rate his/her 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.”

 

PATIENT GLOBAL IMPRESSION OF SEVERITY (PGI-S):

The patient will rate his/her impression of change in severity of symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The PGI-S is a 7-point scale ranging from a score of 1, “normal” to a score of 7, “among the most extremely ill.”

PATIENT GLOBAL IMPRESSION OF CHANGE (PGI-C):

The patient will rate his/her impression of change of symptoms from the baseline (ie, pre-injection) of each treatment session to the time of assessment. The PGI-C is a 7-point scale ranging from a score of 1, “very much improved” to a score of 7, “very much worse.”

DROOLING FREQUENCY AND SEVERITY SCALE (DFSS):

Performed by a blinded assessor.

Frequency:

Assessed on a 4-point scale ranging from 1 (never drools) to 4 (constantly drools).

Severity

Assessed on a 5-point scale ranging from 1 (dry, never drools) to 5 (profuse, clothing, hands, tray, objects become wet).

Total Score

The DFSS total score ranges from 2 (dry and never drools) to 9 (profusely wet and constantly drooling).

DROOLING IMPACT SCALE (DIS):

A 10-item questionnaire with each item rated by the patient to evaluate the impact of sialorrhea on daily activities (eg, speech, social activities). For each question, the patient was requested to compare their current status to their last study visit using a 4-point scale ranging from 1 (not at all) to 4 (very much).
The DIS total score ranges from 10 (not at all impacted) to 40 (very much impacted).

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

The effects of MYOBLOC® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
    • Cervical Dystonia: Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
    • Pre-Existing Neuromuscular Disorders: Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.
  • Human Albumin and Transmission of Viral Diseases
    This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.

References:

1. MYOBLOC® US Prescribing Information. Solstice Neurosciences, LLC. 2. Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson’s disease: a prospective double-blind trial. Mov Disord. 2012;27(2):219-226. doi:10.1002/mds.23929 3. Arezzo JC. NeuroBloc/Myobloc: unique features and findings. Toxicon. 2009;54(5):690-696. doi:10.1016/j.toxicon.2009.03.009 4. Guidubaldi A, Fasano A, Ialongo T, et al. Botulinum toxin A versus B in sialorrhea: a prospective, randomized, double-blind, crossover pilot study in patients with amyotrophic lateral sclerosis or Parkinson’s disease. Mov Disord. 2011;26(2):313-319. doi:10.1002/mds.23473 5. Data on file. Supernus Pharmaceuticals Inc.

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

The effects of MYOBLOC® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
    • Cervical Dystonia: Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
    • Pre-Existing Neuromuscular Disorders: Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.
  • Human Albumin and Transmission of Viral Diseases
    This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of MYOBLOC may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.