DAXXIFY Now FDA-Approved for the Treatment of Cervical Dystonia

 

In 2022, the U.S. Food and Drug Administration (FDA) approved DAXXIFY® (DaxibotulinumtoxinA-lanm) for the temporary treatment of fine lines and wrinkles. Many people touted DAXXIFY as a “Botox alternative.” However, results from the Phase 3 ASPEN 1 and ASPEN OLS (open-label study) trials highlight the potential for DAXXIFY to reduce the symptoms and burden of cervical dystonia, a rare and chronic movement disorder. Currently, people with cervical dystonia have to wait 12 weeks between treatments before they can be re-treated; unfortunately, symptoms often reemerge between weeks 8-10. DAXXIFY offers a route to reduce symptom reemergence and provide some relief to those affected. As shared by biotechnology company Revance Therapeutics, Inc. (“Revance”), the developer of DAXXIFY, the FDA recently granted the drug approval for cervical dystonia in adults.

DAXXIFY is a peptide-formulated, long-acting neuromodulator that is delivered via intramuscular injection. The Phase 3 studies evaluated its efficacy in treating cervical dystonia symptoms. 382 individuals enrolled in the studies. Participants received various DAXXIFY doses, including 125U, 250U, and 300U. The studies found that DAXXIFY was effective in reducing symptoms and improving dysphagia (difficulty swallowing).

The drug was also safe and well-tolerated, though some adverse reactions did occur. These included headache, drooping eyelids, injection site reactions, upper respiratory tract infections, muscle weakness, and facial paralysis.

If you are taking DAXXIFY and experiencing any side effects, you may report them to:

Learn more about DAXXIFY here.

Learning about Cervical Dystonia

Also known as spasmodic torticollis, cervical dystonia is characterized by involuntary muscle contractions in the neck. Cervical dystonia is considered focal, which means it is localized to one area. In this case, the neck muscles contract and pull the head forward and backward, leading to awkward posture in the head, neck, and shoulders. These spasms may be continuous or happen intermittently. But dealing with these involuntary movements can impact quality-of-life and daily activities, making it more difficult to complete tasks.

Cervical dystonia occurs in females 2x more commonly than in males. While it can occur at any age, it is most common in middle age. If cervical dystonia is found in infants or children, doctors should consider a possible secondary illness or cause such as neck trauma or toxins. Doctors do not yet understand the cause of primary cervical dystonia (which occurs without an underlying condition).

Symptoms and severity of this condition can vary from person-to-person but may include:

  • Severe neck pain
  • Abnormal head and neck movements, including a chin or ear twisting towards the shoulder, the head tilting to one side, or the head shifting or tilting forward or backward
  • Headaches
  • Hand tremors
  • Cervical spine arthritis
  • Compressed nerves
  • Cervical stenosis

Symptoms may worsen with excitement or heightened emotions. In an extremely small subset of individuals (1%), this condition enters spontaneous remission. For others, treatment may involve medication, surgery, physical therapy, stress management, or botulinum toxin injections.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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