The market for neuromodulators is expected to replenish. This was stated by the American company Revance Therapeutic Inc. – a pioneer in the field of biotechnology, whose main activity is – development of innovative aesthetic and therapeutic procedures. This is injectable daxibotulinum toxin A (DAXI): an application for licensing the drug was filed with the FDA on February 6, 2020. Perhaps, already on November 25, 2020, the application will be approved and the drug will go on sale. What is known about DAXI and how it differs from competitors, tell estet-portal.com.
- What is the new generation DAXI neuromodulator
- What to Expect from the New: Benefits of DAXI
- Efficacy studies of daxibotulinum toxin A
What is the new generation DAXI neuromodulator
Injectable daxibotulinum toxin A (DAXI) – a new generation neuromodulator designed to correct moderate to severe glabellar (eyebrow) wrinkles.
According to the manufacturer, provides unparalleled efficacy and duration of effect.
Read also: Botulinum toxin: the hottest news of botulinum therapy
The next generation neuromodulator combines a patented stabilizing peptide excipient and a highly purified botulinum toxin that contains no human or animal origin ingredients. This composition makes DAXI safer and minimizes the risk of allergic reactions to the product.
What to Expect from the New DAXI Benefits
The new American botulinum toxin is expected to provide an effect lasting at least 6 months. While currently available neuromodulators "keep" 3–4 months.
So the benefits of DAXI for patients are clear – only 2 botulinum toxin treatments per year instead of 3–4.
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At the same time, we should not forget that complications after botulinum toxin injections, such as drooping of the eyelid, with DAXI will longer.
Daxibotulinum toxin A efficacy studies
DAXI was studied in three Phase III trials (SAKURA 1, 2, 3). This is the largest clinical program aimed at studying the correction of eyebrow wrinkles with a neuromodulator. The results of the SAKURA 1 and SAKURA 2 studies have been published in Plastic and Reconstructive Surgery and Journal of the American Academy of Dermatology.
The pending DAXI approval marks the first major innovation to enter the neuromodulator market in over 30 years.
The effectiveness of daxibotulinum toxin A in the correction is also being evaluated:
- forehead wrinkles;
- lateral canthal wrinkles (crow's feet);
as well as treatment:
- cervical dystonia;
- spasticity of the upper extremities in adults;
- plantar fasciitis.
There are also plans to conduct studies on the treatment of migraines with a new botulinum toxin.
«Our goal – create a new category of premium long-acting neuromodulators", – said Revance President Mark Foley.
In addition to DAXI, Revance has also begun developing a BOTOX® biosimilar.
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