Daewoong Pharmaceutical Botulinum Toxin Demonstrates 6-Month Long-Term Efficacy in High-Dose Clinical Trial
Partner Company Evolus,
Final Announcement of Phase 2 Clinical Trial with Double the Dosage Capacity
Daewoong Pharmaceutical's high-dose botulinum toxin (BTX) formulation has proven long-lasting effects for 6 months.
Daewoong Pharmaceutical's botulinum toxin Nabota's US product, 'Jeuveau'.
[Photo by Daewoong Pharmaceutical]
Daewoong Pharmaceutical announced on the 10th that Evolus, its US-Europe partner in the BTX formulation business, has released the final results of the Phase 2 clinical trial for the high-dose toxin.
Through the Phase 2 trial, Evolus confirmed the long-lasting effect of the high-dose 40-unit Jeubo for 6 months (26 weeks). The clinical results were disclosed on the 3rd (local time) at the American Society for Dermatologic Surgery (ASDS) held in Chicago.
This clinical trial measured the improvement and duration of effect of the high-dose 40-unit Jeubo on glabellar lines using the Glabellar Line Scale (GLS), which quantifies the degree of glabellar wrinkles. Based on the glabellar line scale at the patient's maximum frown, the effect was measured by subdividing into ▲the time it takes for the patient to return to their original glabellar line scale after treatment ▲the duration of effect in patients who showed improvement in glabellar lines ▲and the post-treatment improvement assessment scale (GAIS).
In the clinical trial, the active control group for the 40-unit Jeubo was set as 20 units of Botox and 20 units of Jeubo. According to Evolus, the adverse event results were similar to those of the active control group, and no serious adverse events were found. In June, Evolus also revealed the 6-month long-lasting effect through the interim results of the Phase 2 trial of the 40-unit Jeubo.
With the successful completion of the Phase 2 trial by Evolus, Daewoong Pharmaceutical explained that it has secured flexibility in the treatment cycle of the high-dose 40-unit Jeubo, enabling it to offer various options to patients.
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Park Sung-soo, Vice President of Daewoong Pharmaceutical, said, "This clinical trial has proven the long-lasting effect and safety of Jeubo," adding, "Daewoong and Evolus will further expand their global market share."
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