Clinical information

Demonstrated efficacy

In clinical trials, overall treatment success required at least a 2-grade improvement from baseline by both investigator and subject assessments.

Rapid

MORE THAN HALF
SAW IMPROVEMENT
2-3
DAYS
AFTER TREATMENT1-3*

Enduring

EFFICACY
MAY LAST UP TO
4
MOS.
 

*A secondary endpoint based on Kaplan-Meier estimates the cumulative rate of time to onset of response. The median time to onset of response was 3 days in GL-1 (Dysport 55/105 [52%], Placebo 3/53 [6%] and GL-2 (Dysport 36/71 [51%], Placebo 9/71 [13%]), and 2 days in GL-3 (Dysport 110/200 [55%], Placebo 4/100 [4%]).1-3

†GL-1 and GL-3 evaluated subjects for at least 150 days following treatment. Based on investigator assessment, response was maintained for up to 4 months in both GL-1 (Dysport 24/105 [23%], Placebo 2/53 [4%]) and GL-3 (Dysport 58/200 [29%], Placebo 1/100 [1%]).2-4

  • Success was defined as post-treatment glabellar line severity of none or mild for the combined investigator and subject assessments (composite assessment) on Day 30 with at least a 2-grade improvement.5 The following scale was used to assess efficacy at maximum frown:
    0 none
    1 mild
    2 moderate
    3 severe
  • A subject had to improve from a score of 3 (severe) to a score of 1 or 0 (mild or none), or a score of 2 (moderate) to a score of 0 (none) in order to meet the requirements for overall treatment success.

Study design

Three double-blind, randomized, placebo-controlled clinical studies evaluated the efficacy of Dysport® for use in the temporary improvement of the appearance of moderate to severe glabellar lines. These 3 studies enrolled healthy adults (ages 19–75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had marked ptosis, deep dermal scarring, or a substantial inability to lessen glabellar lines, even by physically spreading them apart. The subjects in these studies received either Dysport or placebo. The total dose was 50 units delivered in equally divided aliquots to specified injection sites.

Additional endpoints for each of the studies were post-treatment glabellar line severity of none or mild with at least a 1-grade improvement from baseline for separate investigator and subject assessments at Day 30.

  • Studies GL-1 and GL-3 were 6- and 5-month (respectively) single-dose studies comparing Dysport to placebo
  • GL-2 was a study of Dysport vs placebo in subjects who had received up to 4 treatments of Dysport over the course of the study

Demonstrated results

Investigator and Subject Assessment of 1+ Grade Improvement in Glabellar Line Severity at Maximum Frown (Study GL-3)
Investigator and Subject Assessment of 1+ Grade Improvement in Glabellar Line Severity at Maximum Frown (Study GL-1)

Repeatable results

Improvement demonstrated with up to 4 repeated treatments5,8

Improvement in glabellar line severity at maximum frown at Day 30 after up to 4 treatment cycles (Study GL-2)5,8
Dysport 1+ grade
N=71
Placebo 1+ grade
N=71
Investigator assessment 85%
(60/71)
4%
(3/71)
Subject assessment 79%
(56/71)
1%
(1/71)

GL-2 was a repeat-dose, double-blind, multicenter, randomized, placebo-controlled study. The study was initiated with 2 or 3 open-label treatment cycles of 50 units of Dysport. After the open-label treatments, subjects were randomized to receive either placebo or 50 units of Dysport. Subjects could have received up to 4 treatments. Efficacy was assessed in the final randomized treatment cycle. The study enrolled 311 subjects into the first treatment cycle, and 142 subjects were randomized into the final treatment cycle.

  • At Day 30, 52% of Dysport-treated subjects achieved treatment success: a composite 2-grade improvement of glabellar line severity at maximum frown.
  • Proportion of responders in the final treatment cycle was comparable to a proportion of responders in all prior treatment cycles5

Treatment-emergent adverse events

Treatment-emergent adverse events (TEAEs) with >1% incidence**
Adverse events by body system Dysport n=398 (%)a Placebo n=496 (%)a
Any TEAE 48 33
Eye Disorders    
Eyelid Edema 2 0
Eyelid Ptosis 2

<1

Gastrointestinal Disorders    
Nausea 2 1
General Disorders and
Administration Site Conditions
   
Injection Site Pain 3

2

Injection Site Reaction 3 <1
Infections and Infestations    
Nasopharyngitis 10 4
Upper Respiratory Tract Infection 3 2
Sinusitis 2

1

Investigations    
Blood Urine Present 2 <1
Nervous System Disorders    
Headache 9 5
**Subjects who received treatment with placebo and Dysport are counted in both treatment columns.

TEAEs were generally mild to moderate5,6,8

  • Safety studied for up to 12 repeat administrations
  • Eyelid ptosis rates (2%)—incidence did not increase with multiple retreatments in long-term studies

Immunogenicity information5

  • As with any therapeutic proteins, there is a potential for immunogenicity.
  • The incidence of antibodies among products in this class varies depending on the sensitivity and specificity of the assay. Comparisons of the incidence of antibodies across products in this class may be misleading.
  • There was no evidence of neutralizing antibodies in 1,554 clinical study patients who received up to 9 treatment cycles of Dysport for the treatment of moderate to severe glabellar lines.
  • Two subjects (0.13%) tested positive for binding antibodies at baseline, and 3 additional patients tested positive for binding antibodies after receiving Dysport treatment. None of the patients tested positive for neutralizing antibodies.

Clinical safety

Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.

DOSAGE AND ADMINISTRATION
The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

CONTRAINDICATIONS

  • Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
  • This product may contain trace amounts of cow's milk protein. Patients known to be allergic to cow's milk protein should not be treated with Dysport.
  • Dysport is contraindicated for use in patients with infection at the proposed injection site(s).

WARNINGS AND PRECAUTIONS
Pre-existing Neuromuscular Disorders

  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction 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 Dysport.

Please see additional Important Safety Information, including Boxed Warning, for Dysport below.

References
  1. Additional study information for GL-2: Data on file, Galderma Laboratories, L.P.
  2. Additional study information for GL-3: Data on file, Galderma Laboratories, L.P.
  3. Additional study information for GL-1: Data on file, Galderma Laboratories, L.P.
  4. Dysport for Injection Package Insert. Scottsdale, Arizona. Galderma Laboratories, L.P.; March 2012.
  5. Dysport Prescribing Information. Galderma Laboratories, L.P. Fort Worth, TX. July 2015.
  6. CSR Y-97-52120-718. July 2007. Data on file, Galderma Laboratories, L.P.
  7. CSR Y-97-52120-719. July 2007. Data on file, Galderma Laboratories, L.P.
  8. CSR Y-97-52120-085. September 2007. Data on file, Galderma Laboratories, L.P.

IMPORTANT SAFETY INFORMATION

Indication: Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.

Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.

CONTRAINDICATIONS

DOSAGE AND ADMINISTRATION

The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

WARNINGS AND PRECAUTIONS

Facial Anatomy in the Treatment of Glabellar Lines

Pre-existing Neuromuscular Disorders

Human Albumin

Intradermal Immune Reaction

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Dysport Full Prescribing Information, including Medication Guide.