SEOUL -- Daewoong Pharmaceutical, a bioengineering company in South Korea, has applied for state approval to use Nabota, a botulinum toxin product developed for the treatment of frown lines, as the treatment of benign masseteric hypertrophy (square jaw) based on the positive results of a final clinical study.
Benign masseteric hypertrophy is a relatively uncommon condition that can occur unilaterally or bilaterally. Unilateral- or bilateral hypertrophy of the masseter muscle is characterized by an increase in the volume of the muscle mass, especially in Asians where masseter hypertrophy is a common facial feature.
Botulinum toxin (botox) is a neurotoxic protein produced by the Clostridium botulinum and related species. Daewoong said it has submitted a new drug application (NDA) to the Ministry of Food and Drug Safety for Navota's indication in correcting benign masseteric hypertrophy.
Daewoong said that the application was based on the results of its phase 3 clinical study conducted in a double-blinded manner to evaluate the effectiveness and safety of Nabota. Some 180 adults were administered one random dose of Nabota or placebo every four weeks for 24 weeks.
Daewoong claimed to have acquired statistical significance in all evaluation variables, with more than 80 percent of the subjects expressing satisfaction. No serious drug-related abnormalities were reported. An extended test was conducted to confirm the effectiveness of repeated administration.
"If we add the world's first indication of improving benign masseteric hypertrophy, (Nabota) will take a step closer to the global No. 1 botulinum toxin with various beauty indications," Daewoong's vice president Park Sung-soo said in a statement on April 21.
Nabota was found to have four indications -- facial wrinkles, upper limb muscle stiffness after stroke, eye wrinkles, eyelid spasms, and upper limb muscle stiffness after stroke, Daewoong said, adding that clinical trials approved by the U.S. Food and Drug Administration (FDA) are underway to confirm the efficacy of Nabota in migraine and cervical dystonia.
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