Revance Receives Permanent J-Code for DAXXIFY and Announces Publication of DAXXIFY Pivotal Study (ASPEN-1) Results in Neurology - Seite 2

The pivotal Phase 3 clinical study (ASPEN 1), included 301 patients randomized to receive 125 U or 250U of DAXXIFY, or to placebo.^1-2 DAXXIFY was shown to be effective, generally safe, and well tolerated across both dose groups, 125U and 250U. ^1-2 The primary endpoint was met in both groups, with 12.7 and 10.9 point reductions from baseline in Total TWSTRS score averaged over Weeks 4 and 6 (p<0.01 vs placebo).^1-2 Median duration of effect, defined as >80% loss of peak effect, was 24.0 and 20.3 weeks for the two dose groups respectively. ^1-2 The low incidence rates of dysphagia (1.9% and 3.6%, respectively) and muscle weakness (4.7% and 2.3%, respectively), further support DAXXIFY’s safety profile.^1-2 The Phase 3 clinical program also included a repeat-treatment, open-label safety study (ASPEN OLS) that allowed for up to 4 additional DAXXIFY treatments, which reinforced the findings of ASPEN-1.³

The total U.S. therapeutic neuromodulator market opportunity for DAXXIFY is $2.7 billion, which includes the over $350 million cervical dystonia market.⁴

The full publication can be accessed via Neurology.org.

DAXXIFY (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS

DAXXIFY (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.

WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.

IMPORTANT SAFETY INFORMATION

Contraindications
DAXXIFY contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency units of DAXXIFY are not interchangeable with preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.