MY PLAN:
Consider a proven treatment option for my patients.

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MYOBLOC has demonstrated efficacy in treating CD in 11 clinical studies.1


MECHANISM OF ACTION2,3

Blocks the release of acetylcholine (ACh) to inhibit muscle contraction.

  • MYOBLOC has been demonstrated to cleave synaptic vesicle-associated membrane protein (VAMP)*
  • This blocking action allows the injected muscle to assume a more normal tone
Microscopic image of the neurospecific binding of the toxin on the presynaptic nerve surface

1. BINDING
Neurospecific binding of the toxin on the presynaptic nerve surface

Microscopic image showing internalization of the toxin by receptor-mediated endocytosis

2. INTERNALIZATION
of the toxin by receptor-mediated endocytosis

Microscopic image showing subsequent translocation of the toxin light chain into the cytosol

3. TRANSLOCATION
Subsequent translocation of the toxin light chain into the cytosol

Microscopic images showing cleavage of the synaptic vesicle-associated membrane protein

4. CLEAVAGE
Modificaion of an intracellular target substrate that governs the docking and fusion of ACh-containing vesicle


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

EFFICACY IN CERVICAL DYSTONIA

As the first botulinum toxin injection approved by the FDA for CD, MYOBLOC is a well-studied treatment with demonstrated efficacy in adults2

Click each to see specific data  

For definitions of rating scales and measurements click here  

Study 44

A randomized, double-blind, multicenter, placebo-controlled, 16-week trial

  • 122 patients enrolled
  • 4 dose arms: 2,500 Units (n=31), 5,000 Units (n=31), or 10,000 Units (n=30) vs. placebo (n=30)
  • Objectives: Determine the safety and efficacy of MYOBLOC in both A-responsive and A-resistant patients with CD

TOXIN A-RESPONSIVE AND TOXIN A-RESISTANT PATIENTS2,4

Significant pain relief as early as 2 weeks.

Bar graph showing improved TWSTRS-total score and TWSTRS-pain score at Week 4 in doses tested

Study 15

A randomized, double-blind, multicenter, placebo-controlled, 16-week trial

  • 109 patients enrolled
  • 3 dose arms: 5,000 Units (n=36) or 10,000 Units (n=37) vs. placebo (n=36)
  • Objectives: Determine the safety and efficacy of MYOBLOC in patients with CD who were responsive to Toxin Type A

TOXIN A-RESPONSIVE PATIENTS2,5

Fast and effective pain relief

Bar graph showing mean change (improvement), baseline to Week 4 for TWSTRS-total and TWSTRS-pain score

Study 26

A randomized, double-blind, multicenter, placebo-controlled, 16-week trial

  • 77 patients enrolled
  • 2 dose arms: 10,000 Units (n=39) vs. placebo (n=38)
  • Objectives: Determine the safety and efficacy of MYOBLOC in patients with CD who were resistant to Toxin Type A

TOXIN A-RESISTANT PATIENTS2,6

Significant pain relief in as early as 2 weeks

Bar graphing showing mean change (improvement), baseline to Week 4 for TWSTRS-total and TWSTRS-pain score at 10,000 units

Although there was a MYOBLOC-associated decrease in pain, many patients remained who experienced an increase in dystonia-related neck pain irrespective of treatment group

Study 4027

A randomized, double-blind, multicenter, noninferiority trial

  • 93 patients new to treatment with botulinum toxins were analyzed7
  • 2 dose arms: BOTOX 150 Units (n=47) or MYOBLOC 10,000 Units (n=46)
  • Objectives: Compare the efficacy, safety, and duration of effect of BOTOX with MYOBLOC in toxin-naive patients with CD

TOXIN-NAIVE PATIENTS
Head-to-head study: MYOBLOC vs. BOTOX®

Noninferiority of MYOBLOC vs. BOTOX was established7

Table comparing the TWSTRS-total score and TWSTRS-pain score between MYOBLOC 10,000 units and BOTOX 150 units

Long-Term, Open-Label Study1,8

427 patients (mean age, 55.1 years) enrolled in the multicenter study, which represented the largest prospective report of long-term, open-label MYOBLOC treatment in CD. On the first injection, patients were administered 5,000 Units (toxin-naive patients who previously received placebo), 10,000 Units, or the highest MYOBLOC dose previously received. Re-injection occurred when the patient returned to approximate CD baseline status at least 3 months from their last injection. TWSTRS scales were performed at baseline and 4 weeks post-treatment.

Line graph showing mean change (improvement) at Week 4 following each injection

Persistent pain relief effect at Week 4 following each injection in this large, prospective, multicenter, open-label extension trial


Patients demonstrated improvements of baseline TWSTRS scores through 12 treatment sessions

MYOBLOC provided lasting, effective relief of abnormal head posture and neck pain in CD for up to 16 weeks2

Proven to relieve the severity of abnormal head position and neck pain associated with CD in adults.

2 Weeks

PAIN RELIEF
as early as

4 Weeks

SIGNIFICANT
improvement in head posture by

12-16 Weeks

DURATION
of action

Bottle icon with a checkmark in it

READY TO USE
and requires no mixing2

SAFETY & TOLERABILITY2

Table comparing adverse reactions across 2,500 units, 5,000 units, 10,000 units and a placebo.

Safety profile comparable to BOTOX*,7

Table comparing adverse events between MYOBLOC and BOTOX

*Categories of interest have been defined as “dry mouth,” “dysphagia,” and “injection-site pain” because they represent frequent adverse events that have been associated with both botulinum toxin serotypes; treatment-related incidence is the same as overall incidence for these events. No other treatment-related adverse events occurred in >10% in either BOTOX or MYOBLOC in the intent-to-treat population.

Fisher’s exact test (BOTOX vs. MYOBLOC).

RATING SCALES AND MEASUREMENTS EXPLAINED:

TWSTRS: A VALIDATED SCALE FOR ASSESSING CERVICAL DYSTONIA2,9

TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is frequently used in clinical trials for cervical dystonia, including trials for MYOBLOC.

It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score, which is scored from 0-87 (best to worst).

Abbreviation: TWSTRS, Toronto Western Spasmatic Torticollis Rating Scale.

VISUAL ANALOG SCALE (VAS)2,9

The VAS is a subjective scale used for assessing a variable such as patient-reported pain. It is a 100-mm line, usually horizontal, anchored on both ends with descriptors (0=Worst ever pain, 100=No pain). A patient marks the point that he/she feels represents the variable being measured (eg, pain). The score, from 0 to 100, is determined by measuring from the end of the line to the patient's mark. A 100-point VAS was used in pivotal clinical trials for MYOBLOC.

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. Data on file. Solstice Neurosciences, LLC 2. MYOBLOC. Prescribing Information. Solstice Neurosciences, LLC. 3. Montecucco C, Papini E, Schiavo G. Bacterial protein toxins penetrate cells via a four-step mechanism. FEBS Lett. 1994;346(1):92-98. 4. Lew MF, Adornato BT, Duane DD, et al. Botulinum toxin type B: a doubleblind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology. 1997;49(3):701-707. 5. Brashear A, Lew MF, Dykstra DD, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology. 1999;53(7):1439-1446. 6. Brin MF, Lew MF, Adler CH, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999;53(7):1431-1438. 7. Pappert EJ, Germanson T. NeuroBloc botulinum toxin type B vs type A in toxin-naive patients with cervical dystonia: randomized, double-blind, non-inferiority trial. Mov Disord. 2008;23(4):510-517. 8. Lew MF, Factor SA. Botulinum toxin type B (Myobloc) is well tolerated and efficacious in a long-term observational study: results of an open-label extension trial of repeated dosing in subjects with cervical dystonia. Poster presented at: American Association of Neurology Annual Meeting; April, 2006; San Diego, CA. 9. Lew MF. Botulinum toxin type B: an effective treatment for alleviating pain associated with cervical dystonia. J Back Musculoskel Rehab. 2002;16(1):3-9.

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.