The Largest Phase 3 Clinical Trial Program conducted for a neuromodulator to treat glabellar lines1
- Forehead Lines Phase 2
- Lateral Canthal Lines Phase 2
- Upper Facial Lines Phase 2
- Cervical Dystonia Phase 3
- Upper Limb Spasticity Phase 2
Achieved wrinkle severity of none or mild at week 4 per investigator’s assessment.
Achieved a ≥2-grade improvement at week 4 per investigator’s assessment. 74% achieved a ≥2-grade improvement at week 4 per both investigator’s and patient’s assessments
Of patients were satisfied with their treatment at week
Median time to loss of none or mild wrinkle severity per both investigator’s and patient’s assessments
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 glabellar lines.
In the repeat-dose, open-label SAKURA 3 safety study, 2,691 patients were treated with 40U of DAXXIFY®. The adverse reaction profile was similar to that reported in single-dose trials.
Injection site reactions were the most common adverse reactions, reported in 9% of patients [including injection site pain (4%), injection site erythema (3%), injection site edema (3%), injection site bruising (1%), injection site papule (<1%), and injection site pruritus (<1%)], followed by headache (5%), edema (2%), erythema (2%), and eyelid ptosis in 1% of patients.
The incidence of these adverse reactions did not increase with multiple retreatments.
The potency Units of DAXXIFY® are not interchangeable with other 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.