Daewoong Pharmaceutical said it completed a phase 3 clinical trial of Nabota, a botulinum toxin treatment, aimed to win indication for benign masseter hypertrophy, and applied for a marketing license of Nabota.
On Thursday, the company said it applied to the Ministry of Food and Drug Safety for adding the indication of Nabota to reduce benign masseter hypertrophy, or the so-called “square jaw.”
The permit application was based on the local phase 3 study results on 180 adult patients who needed benign masseter hypertrophy improvement.
In the randomized, double-blind study, Nabota or placebo was assigned randomly to the patients. After a single dose of either drug, researchers evaluated the efficacy and safety every four weeks for 24 weeks.
According to Daewoong, the primary endpoint was set as a change from baseline in masseter muscle thickness at week 12 after the drug administration. The researchers confirmed that the patients treated with Nabota had a 20 percent or more reduction in change from baseline in masseter muscle thickness, which is more than seven-folds compared to that of the placebo group.
The study met all endpoints with statistical significance -- the maximum occlusion at each evaluation point compared to the baseline, the average change and average rate of change in masseter muscle thickness on both sides in normal times, and the average rate of change in the normal lower face volume through 3D facial contour analysis, and patient satisfaction.
More than 80 percent of the participants said they were satisfied with the results, and the study did not report any serious drug-related adverse events.
To confirm the effect of repeated administration, Daewoong conducted an extension study. After repeated administration, the effect increased compared to the first administration in terms of change from baseline in masseter muscle thickness on both sides at week 12.
Nabota has four indications -- glabellar wrinkles, upper extremity muscle stiffness after a stroke, eye wrinkles, and eyelid cramps.
Other Korean BTX makers are also conducting trials to add square jaw reduction indication.
Huons Biopharma said on April 4 that it ended the local phase 2 study of Liztox (export name: Hutox) to improve benign masseter hypertrophy.
Huons Biopharma confirmed Liztox’s effect to improve benign masseter hypertrophy in adults who needed symptom improvements in the phase 2 trial. In addition, the company said that Liztox did not cause any abnormality in terms of safety compared to the existing BTX type-A product.
Huons Biopharma plans to prepare for a phase 3 study immediately. The company expects to win the indication for benign masseter hypertrophy in the second half of 2024.
In 2020, Medytox said it would add a square jaw reduction indication.
The Korean BTX makers expect that winning the indication for benign masseter hypertrophy will allow physicians to use BTX instead of surgical treatment and raise the competitiveness of BTX products.
The global BTX market size was about $5 billion in 2020, and it is expected to grow to more than $6 billion in 2023. As a result, the square jaw BTX market is also likely to expand.