Fleqsuvy™

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

Background

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

Questions?

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