17 Aug 2023 • The US FDA has expanded the approval for daxibotulinumtoxinA-lanm injection (Daxxify, Revance Therapeutics) to include the treatment of cervical dystonia in adults. This marks the first therapeutic indication for Daxxify, which was previously approved for improving the appearance of glabellar (frown) lines in adults. The approval is based on data from the phase 3 ASPEN clinical program, involving 382 patients with moderate to severe cervical dystonia. The ASPEN-1 study showed that Daxxify was effective, safe, and well-tolerated, with a median duration of effect of 24 and 20.3 weeks for different dose groups. Side effects were minimal, and the rates of adverse events like neck weakness and dysphagia were low compared to other botulinum toxin treatments for cervical dystonia. Additionally, the ASPEN OLS study indicated that symptom improvement continued with successive treatments at doses up to 300U, while maintaining low adverse event rates. Source: Medscape | Read full story