Aquavit News: Company Files Investigational New Drug Application for Dermatox

Aquavit is the first company 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. 

Aquavit has filed an Investigational New Drug Application with the U.S Food and Drug Administration (FDA) for Dermatox (aqubotulinumtoxinA), their intradermal injection of botulinum toxin.

AqubotulinumtoxinA has already received regulatory approvals 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),” will look at temporary improvement of mild to moderate face and neck lines and skin quality in adults younger than 65 years of age.

Aquavit is the first company 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. 

"We are excited about the clinical trials of Dermatox™ and strongly believe in its ability to thrive in the ultra-competitive dermatology space," says Sobin Chang, MPH, CEO of Aquavit, in a news release.

"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," adds Churlsu Kwon MD PhD MPH, CMO of Aquavit.