Galderma Announces Top-line Results from Phase 2 Clinical Dose-Escalating Study with Azzalure® / Dysport® (abobotulinumtoxinA)
Galderma today announced top-line results from a Phase 2 study on the impact of dose escalation on the duration of effect and the efficacy and safety of a single dose of Dysport ® (abobotulinumtoxinA) for Injection (50U, 75U, 100U or 125U) versus placebo for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines). Results showed that the study met its primary endpoint, with significantly more subjects treated with Dysport ® at all four doses achieving a composite two grade improvement responder rate than those treated with placebo at one month. Data from secondary endpoints demonstrated promising results for a potential prolonged duration of effect correlated with higher doses. Dysport ® , also marketed as Azzalure® in some countries, is a prescription injection for temporary improvement in the look of moderate to severe glabellar lines in adults less than 65 years of age.
“We are encouraged that these study results demonstrate that a single dose of Dysport ® has a rapid onset, long-lasting effect and is well tolerated,” said John H. Joseph, M.D., investigator for the study and director of The Clinical Testing Center of Beverly Hills. “At all doses tested in the trial, Dysport ® had a strong safety profile, including very few cases of eyelid ptosis.”
Phase 2 Dose-Escalating Study Design and Results
The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Study participants were randomized 4:1 to receive a single dose of Dysport ® (50U, the dose in the FDA-approved label, 75U, 100U or 125U) or placebo and followed for nine months. The primary objective of the study was to evaluate the efficacy of a single dose of Dysport ® as assessed by the composite responder rate at maximum frown at one month. Secondary objectives evaluated other measures of efficacy as well as duration of treatment response, subject satisfaction, aesthetic improvement and onset of treatment response.
Top-line efficacy results showed that the study met its primary endpoint. After one month, all dose groups treated with Dysport ® showed a statistically significant composite (investigator and subject-assessed) ≥2-grade improvement when compared with placebo. Favorable results were achieved for all doses in the secondary objectives, including a ≥1-grade improvement and subject satisfaction throughout the study duration. Dysport ® was well tolerated with a similar safety profile across all doses tested. Treatment-related adverse events were mild or moderate in severity and transient, and no treatment-related serious adverse events were reported.
“This phase 2 study underscores our commitment to bring efficacious products and long-lasting results to customers,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “Based on these encouraging safety and long-term efficacy results, as well as continued patient satisfaction, we are evaluating future clinical studies.”
About Galderma's collaboration with Ipsen
Dysport ® (abobotulinumtoxinA) is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure® in the EU for the treatment of glabellar lines with more than 40 million treatments in the EU and U.S. combined and with approvals in 74 countries.
is manufactured by Ipsen, a global specialty-driven pharmaceutical company. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen's botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, the European Union, Australia, South Korea, Canada, Brazil, Argentina, and certain other countries. Ipsen continues to promote Dysport
within certain therapeutic indications in countries around the world.
For more information on Ipsen, visit www.ipsen.com .
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com/ .
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Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
The Dysport trademark is used under license. All trademarks are the property of their respective owners.
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