Daewoong Pharmaceutical said Monday that it has published the phase 3 clinical trial results for Nabota, its botulinum toxin (BTX) product, in an international journal.
|Daewoong Pharmaceutical's botulinum toxin Nabota|
The company received approval for Nabota from the U.S. Food and Drug Administration in February. The FDA’s go-ahead has made Nabota the first Korean BTX product to enter the U.S., the world's largest botulinum toxin market.
Daewoong’s U.S. partner Evlous plans to market the treatment as Jeuveau.
The study, conducted in Europe and Canada, was a double-blinded test to confirm the non-inferiority of Nabota when compared with Allergan’s Botox. The company administered either Nabota or Botox to 540 patients, aged 18 years or older, with a Glabellar Line Scale (GLS) of 2 to 3 and measured the primary efficacy after 30 days.
As a result, 87.2 percent of the patients receiving Nabota showed a GLS improvement of 0 or 1 level compared to the 82.8 percent of the patients treated with Botox.
“The result confirmed the non-inferiority of Nabota’s wrinkle-reducing effect compared to Botox,” the company said. “We obtained the same results in the Global Aesthetic Improvement Scales, which evaluates the symptom improvement after receiving BTX.”
Daewoong also reported no drug-related adverse cases.
“It is significant that a clinical study proving the non-inferiority of Nabota compared to Botox was published in international journals,” said Park Sung-soo, head of Daewoong’s Nabota business division. “Nabota is the first 900-kDa product to enter the U.S. market since the launch of Allergan's Botox, and the company expects that the superior efficacy and safety of Nabota, as have been proved through clinical trials, will serve as an incentive for local medical staff and patients.”
The results of the study were published in the latest issue of Aesthetic Surgery Journal.
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