Aquavit Files Investigational New Drug Application for its Flagship Intradermal Injection of Botulinum Toxin
28 Apr 2023
Phase 3Drug Approval
NEW YORK, April 28, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has filed an Investigational New Drug Application with the FDA for its flagship intradermal injection of botulinum toxin, Dermatox™ (aqubotulinumtoxinA). AqubotulinumtoxinA has already received regulatory approvals in other countries in Asia, South America and the Middle East, and is currently under phase III clinical trials in many other territories.
Aquavit's proposed phase II/III study, "Safety and Efficacy of AqubotulinumtoxinA for Enhanced Skin Quality Index (SAFESQIN)", is indicated in the temporary improvement of mild to moderate face and neck lines and skin quality in adults younger than 65 years of age.
Botulinum toxins have been widely utilized for aesthetic and therapeutic indications for over three decades. Aquavit is the first company in history to pursue an FDA approval for intradermal injection of botulinum toxin for the improvement of skin quality and reduction of fine lines for face and neck.
The global botulinum toxin market was valued at USD 4.6 billion in 2021 and is expected to reach USD 7.9 billion by 2026. Aquavit's combination of AqubotulinumtoxinA and its patented microchannel technology (AQT-001) are poised to make a large impact in this space.
For the first time ever, physicians will be able to address thinner layers of the skin safely and effectively to enhance skin quality and reduce fine lines on a broad surface, including the entire area of the face and neck.
"While existing botulinum toxins focus only on intramuscular injections of moderate to severe lines on a very specific area, Dermatox™ would be the first approved for the improvement of overall skin quality, cementing Dermatox™ as a groundbreaking treatment option," added Churlsu Kwon MD PhD MPH, CMO of Aquavit.
About Aquavit Holdings
Aquavit Holdings is a biotechnology company focused on the development of botulinum toxin applications. Aquavit Holdings focuses on personalized applications of botulinum toxins to improve patients' health, maximize the efficiency of our medical community, and support the pharmacoeconomics of payers.
SOURCE Aquavit Holdings
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