Clinical Information

Expand all

Collapse all

Demonstrated efficacy

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

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 improvement¹
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
3 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

Improvement at every time point^1,2
A 5-month, single-dose, double-blind, multicenter, randomized, placebo-controlled study (N=300) to assess the safety and efficacy of 50 Units of Dysport vs placebo in subjects with moderate to severe glabellar lines at maximum frown¹

*statistically significant

^a1+ grade improvement assessed by physicians and patients was a secondary endpoint.
*statistically significant

Improvement demonstrated for up to 4 months^1,3
(also see study GL-3 results above)
A 6-month, single-dose, double-blind, multicenter, randomized, placebo-controlled study (N=158) to assess the safety and efficacy of 50 Units of Dysport vs placebo in subjects with moderate to severe glabellar lines at maximum frown¹

*NS=Not statistically significant

^a1+ grade improvement assessed by physicians and patients was a secondary endpoint.
*NS = Not statistically significant

Clinical safety

IMPORTANT SAFETY INFORMATION

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 injection at the proposed injection sites(s).

The following table reflects exposure to Dysport in 398 subjects aged 19 to 75 who were evaluated in the randomized, placebo-controlled clinical studies that assessed the use of Dysport for the temporary improvement in the appearance of glabellar lines. Adverse events of any cause were reported for 48% of the Dysport-treated subjects and 33% of the placebo-treated subjects. Treatment-emergent adverse events were generally mild to moderate in severity¹.

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

References: 1. Dysport [package insert]. Scottsdale, AZ. Medicis Aesthetics, Inc.; May 2009. 2. Data on file. Medicis Pharmaceutical Corporation, CSR Y-97-52120-718. Draft 4.0. June 2007. 3. Data on file. Medicis Pharmaceutical Corporation, CSR Y-97-52120-719. Draft 5.0. June 2007.

IMPORTANT SAFETY INFORMATION

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 adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

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
Facial Anatomy in the Treatment of Glabellar Lines

Caution should be exercised when administering Dysport to patients with surgical alterations to the facial anatomy, excessive weakness or atrophy in the target muscle(s), marked facial asymmetry, inflammation at the injection site(s), ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart.
Do not exceed the recommended dosage and frequency of administration of Dysport. In clinical trials, subjects who received a higher dose of Dysport had an increased incidence of eyelid ptosis.

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.

Human Albumin

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.
A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.

Intradermal Immune Reaction

The possibility of an immune reaction when injected intradermally is unknown.
The safety of Dysport for the treatment of hyperhidrosis has not been established.

ADVERSE REACTIONS

In clinical studies, the most frequently reported adverse events (>2%) were nasopharyngitis, headache, injection site pain, injection site reaction, upper respiratory tract infection, eyelid edema, eyelid ptosis, sinusitis and nausea.

DRUG INTERACTIONS

Patients treated concomitantly with botulinum toxins and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents) should be observed closely because the effect of the botulinum toxin may be potentiated. Use of anticholinergic drugs after administration of Dysport may potentiate systemic anticholinergic effects such as blurred vision.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of 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 Dysport.

USE IN SPECIFIC POPULATIONS

Dysport is not recommended for use in children or pregnant women.

The Dysport trademark is used under license. All other trademarks are the property of their respective owners.
© 2010 Medicis Aesthetics Inc.

The information in this section of DysportUSA.com is intended for healthcare professionals only. If you are a healthcare professional, please verify by clicking the button below.

If you are not a healthcare professional, we invite you to learn about Dysport by going here.

The product information provided on this site is intended only for healthcare professionals licensed in the United States.