Medytox said Thursday that the Ministry of Food and Drug Safety has approved Coretox, the company’s pure botulinum toxin (BTX) product, in treating stiff upper limb muscles caused by strokes.
|Medytox‘s 3rd BTX product Coretox|
“With the approval, Coretox has secured two indications -- treatment of forehead wrinkles and stiff muscles of the upper limbs after stroke – a year after launching the product, strengthening our position in the beauty and treatment market,” the company said. “
Muscle stiffness after stroke, which happens in one-third of stroke patients, is caused by damage to the central nervous system of the brain. In severe cases, it acts as a critical obstacle to neurological and functional recovery affecting the daily life of the patient.
According to Medytox, the administration of Coretox to the stiff upper limb muscles has the effect of suppressing the excessive contraction of the muscles and alleviating the symptoms.
Coretox eliminated the non-toxic proteins that are not involved in efficacy from a 900-kDa botulinum toxin and refined only the 150 kDa neurotoxin to reduce the risk of resistance development.
In particular, the company managed to exclude the animal components of the botulinum culture medium used in the manufacturing process for the first time in the world. Also, the use of human serum albumin as a stabilizer in the finished product has reduced the possibility of infection with blood-borne pathogens and infectious microorganisms, Medytox said.
Medytox is also conducting clinical trials to expand the indication of the drug in treating idiopathic irritable bladder (clinical phase 3), benign gluteal hypertrophy (clinical phase 3), antiperspirant (clinical phase 3), chronic migraine (clinical phase 2).
The company will also apply to expand indications for benign gluteal hypertrophy and antiperspirant in the first half of this year.
“Coretox, which has a lower risk of tolerance that is much needed in the local high dose cosmetic market, will become the most suitable treatment option,” a company official said. “Medytox has the highest number of treatment indications among local BTX companies and will continue to secure additional indications to help treat more patients.”
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