Local developers of botulinum toxins are increasingly competing to expand the scope of treatments such as excessive sweating inhibition.

Medytox received approval for three clinical trials for Medytoxin this year.

Logos of South Korea's leading botulinum toxin makers

In January, the company won the nod for a study to test Medytoxin’s efficacy and safety in sweating inhibition in healthy male adults. In the following month, the firm obtained approval for a phase-3 trial to assess the drug’s potency to treat benign masseteric hypertrophy. In May, the company also received the green light for a phase-3 study to treat primary axillary hyperhidrosis in 220 local patients.

The original drug Botox by Allergan already has an indication for primary axillary hyperhidrosis.

Medytox is hoping that the expansion of indications will help sell more Medytoxin products in the summer season this year.

Daewoong Pharmaceutical has begun clinical trials on Nabota by researchers at the Seoul National University Hospital. The company received approval on Tuesday for the study to check whether botulinum toxin can maintain an increased leg temperature in lumbar sympathetic ganglion block (LSGB).

Earlier in February, Daewoong won the nod for a study at Inje University Busan Paik Hospital to assess Nabota’s safety and efficacy in chronic simple popliteal or nodular swelling. In April, the company obtained approval for a trial at Hallym University Dongtan Sacred Heart Hospital to treat mild and severe sagging of facial skin through intradermal injection of botulinum toxin.

Hugel is also conducting a trial to assess how Botulax injection affects the volume of the parotid gland in 20 patients at Asan Medical Center.

The study aims to secure the product’s safety for the cosmetic purpose rather than the expansion of indications, observers said.

Injecting botulinum toxin into salivary glands or parotid glands may make a face look smaller than before, they said.

“As local botulinum toxins lack indications compared to the original, domestic drugmakers should catch up through continuous clinical trials. The companies must be seeking to overtake the original drugmaker,” a pharmaceutical source said. “To increase the use of domestic botulinum toxins, it is important to expand the indications and secure safety data. Such clinical trials are expected to continue in the future.”

sjh@docdocdoc.co.kr

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