Delving into the Latest Updates on Botulinum toxin A (BMI Korea) with Synapse

Overview

Basic Info

Drug Type

Toxin

Synonyms

Target

SNAP25

Mechanism

SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)

Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Glabellar frown lines

Inactive Indication-

Originator Organization

BMI Korea Co., Ltd.

Active Organization

BMI Korea Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Botulinum toxin type A (BoNT-A) was first isolated in 1946, and since then, several formulations have been developed and widely used to treat wrinkles by inducing muscle paralysis. This multicenter, double-blind, randomized, parallel-group, active-controlled phase 3 clinical trial was designed to evaluate the efficacy and safety of a newly developed BoNT-A formulation, BMI2006, in improving moderate to severe glabellar wrinkles and to compare with existing onabotulinumtoxin A (OBoNT) injections. A total of 276 subjects were enrolled and received 20 units of the randomized material, which was intramuscularly injected into five different locations on the forehead. The primary endpoint, assessed at 4 weeks, showed no statistically significant difference in the improvement rate of glabellar wrinkles between the two groups, with BMI2006 demonstrating non-inferiority to comparator BoNT-A. Secondary endpoints, evaluated by both treating investigators and independent investigators, also exhibited similar improvement rates throughout the study period. Both groups reported high levels of satisfaction with no statistical difference between the two groups. Safety evaluations indicated mild and transient adverse events, with no serious reactions observed. In conclusion, BMI2006 is an effective and safe BoNT-A for treating glabellar wrinkles with an expected duration of action between 8 and 12 weeks.

100 Deals associated with Botulinum toxin A (BMI Korea)

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