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Drug - Fleqsuvy™ (baclofen oral suspension) [Azurity Pharmaceuticals, Inc.]

October 2022

Therapeutic area - Skeletal muscle relaxants

Initial approval criteria

  • Patient must be at least 12 years of age
  • Patient must have a documented diagnosis of muscle rigidity, muscle spasms, myoclonus, or spasticity due to of one of the following:
    • Multiple sclerosis OR
    • Spinal cord injury/spinal cord disease
  • Patient must have medical documentation of a trial and failure of baclofen tablets or rationale why tablets cannot be used (e.g., gastrostomy tube, dysphagia, etc.)

Renewal criteria

  • Patient continues to meet the initial review criteria AND
  • Documentation of improved clinical response AND
  • Patient has not have experienced any treatment-restricting adverse effects

Quantity limits

  • Dose and dosing frequency is appropriate per FDA-approved label or is supported by compendia


Fleqsuvy is not FDA-approved for the treatment of skeletal muscle spasm resulting from rheumatic disorders.


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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