Clinical information

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

The following scale was used to assess efficacy at maximum frown

• 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

Investigator and subject assessments (composite) in glabellar line severity at maximum frown at day 30¹

Post-treatment glabellar line severity of none or mild with at least a 2-grade improvement from baseline.

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

Improvement at every time point²

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

Improvement demonstrated for up to 4 months³
(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

Improvement demonstrated with up to 4 repeated treatments^1,4

Proportion of responders in the final treatment cycle was comparable to the proportion of responders in all prior treatment cycles¹

Immunogenicity information¹

• There was no evidence of neutralizing antibodies in 1554 clinical study patients who received up to 9 treatment cycles of Dysport for the treatment of moderate to severe glabellar lines.
• As with any therapeutic proteins, there is a potential for immunogenicity.
• The incidence of antibodies among products in this class varies.
• 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.

Safety studied with up to 12 repeated administrations^1,5

In the overall safety database, adverse events were reported for 57% (1425/2491) of subjects. Adverse events that emerged after repeated injections in 2–3% of the population included bronchitis, influenza, pharyngolaryngeal pain, cough, contact dermatitis, injection site swelling, and injection site discomfort.

• The incidence of eyelid ptosis did not increase in the long-term safety studies with multiple retreatments at intervals > 3 months. The majority of eyelid ptosis events were mild to moderate in severity and resolved over several weeks.
• To avoid increased risk of ptosis, adhere to recommended dosage.

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.

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).

Treatment-emergent adverse events

TEAEs were generally mild to moderate^1-3

• TEAEs judged to be possibly or probably related to study treatment occurred in 16% of patients treated with Dysport and 9% of patients treated with placebo
• Eyelid ptosis rates (2%)—incidence did not increase with multiple retreatments in long-term studies¹

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. Dysport package insert. Scottsdale, Arizona. Medicis Aesthetics Inc.; April 2010. 2. CSR Y-97-52120-718. Draft 4.0. June 2007. Data on file, Medicis Pharmaceutical Corporation. 3. CSR Y-97-52120-719. Draft 5.0. June 2007. Data on file, Medicis Pharmaceutical Corporation. 4. CSR Y-97-52120-085. September 2007. Data on file, Medicis Pharmaceutical Corporation. 5. Dysport (Reloxin) BLA, Integrated Safety Summary. April, 2009. Data on file, Medicis Pharmaceutical Corporation.