Daxxify (daxibotulinumtoxinA-lanm) - 2 Indications

• Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients; approved September of 2022
• The treatment of cervical dystonia in adult patients; approved August of 2023

Scroll down for more information on each indication:

General Information

Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent.

Daxxify is specifically 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;
• the treatment of cervical dystonia in adult patients

Mechanism of Action

Daxxify (daxibotulinumtoxinA-lanm) blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine. When injected into skeletal muscle, Daxxify is internalized into the nerve terminal, translocates into the neuronal cytosol where it cleaves SNAP25, a protein necessary for synaptic vesicle membrane docking and subsequent release of acetylcholine which produces a dose dependent decrease of muscle function. Recovery of activity is gradual and results from the degradation of neurotoxin light chain in the neurons with a contribution from the formation of axonal sprouts. Muscle reinnervation occurs, leading to a slow reversal of the pharmacological effects of Daxxify.

Side Effects

Adverse effects associated with the use of Daxxify for glabellar lines may include, but are not limited to, the following:

• headache
• eyelid ptosis
• facial paresis

Adverse effects associated with the use of Daxxify for cervical dystonia may include, but are not limited to, the following:

• headache
• injection site pain
• injection site erythema
• muscular weakness
• upper respiratory tract infection

The Daxxify drug label comes with the following Black Box Warning: 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.

Indication 1 - glabellar lines

• 74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
• 88% achieved > two-grade improvement at week 4 per investigator assessment
• 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
• The median duration of effect was 6-months
• Some patients maintained treatment results at 9 months
• Results seen as early as one day after treatment, typically seen within two days

Indication 2 - cervical dystonia

Daxxify is supplied as an injection for intramuscular use. The recommended dose is 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles.

FDA approval was based on the Phase 3 clinical program (ASPEN 1, ASPEN OLS), which included 382 patients and 1,240 treatments across up to five injection cycles over an 88-week time span.  In the pivotal ASPEN clinical study, Daxxify was shown to be effective, generally safe, and well tolerated across both dose groups, 125U and 250U, with a median duration of effect of 24.0 and 20.3 weeks for the two dose groups respectively. Based on the ASPEN OLS study, symptoms continued to improve with successive Daxxify treatments at doses up to 300U, while adverse events remained low. In particular, dysphagia rates (difficulty swallowing) remained low (2.7% for ASPEN-1 and 4.2% for ASPEN-OLS).