Objectives: To give an overview on prabotulinumtoxin (praBoNTA)
Introduction: PrabotulinumtoxinA (praBoNTA, JeuveauTM, NeuceivaTM, Evolus, Inc. Newport Beach, CA) is one of the new toxins on the market approved for the treatment of glabellar lines in Canada (2018), the US (2019) as well as in Europe (2019). In contrast to other toxins, it will be licensed only for aesthetic indications.
Materials / method: Literature search.
Results: Several RCTs have been conducted to look into the efficacy and safety. One major RCT (EVB 003) included onaBonNTA as comparator. Results from this Phase III clinical trial (n=540) confirmed that a single dose of 20 U praBoNTA was both well-tolerated and non-inferior to 20 U onaBoNTA for the treatment of moderate to severe glabellar lines. Responder rates for the primary efficacy endpoint at day 30 were 87,2 %, 82,8 % and 4,2% for praBoNTA, onaBoNTA and placebo. Further phase II safety studies have been conducted showing an excellent safety profile after long term repeated injections.
Conclusion: PraBoNTA is new efficacious and safe botulinumtoxin preparation. It is approved for the treatment of glabellar lines. In Europe it will be available from fall 2022 on.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo es presentado gracias al apoyo de: Evolus who sponsored the RCT where I participated as an investigqtoe