The Food and Drug Administration (FDA) has approved Fleqsuvy (baclofen oral suspension) for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Fleqsuvy, a gamma-aminobutyric acid (GABA-ergic) agonist, may also be used in patients with spinal cord injuries and other spinal cord diseases.

The approval was based a bioavailability study in healthy adults comparing baclofen oral tablets with Fleqsuvy. Under fasting conditions, results showed similar bioavailability of baclofen at the 20mg dose level for the oral suspension and oral tablet formulations.

Fleqsuvy is supplied as a 25mg/5mL (5mg/mL) oral grape-flavored suspension. Prior to prescribing, dispensing, and administering the concentrated formulation, the strength and dose of the product should be verified. A calibrated measuring device is recommended to measure and deliver the prescribed dose.

Commenting on the approval, Amit Patel, Chairman and CEO of Azurity Pharmaceuticals, said: “The clinical profile of Fleqsuvy allows for a tailored and flexible approach to dosing for patients suffering from spasticity, a debilitating symptom that may impact daily functioning.”

Fleqsuvy is not indicated in the treatment of skeletal muscle spasms resulting from rheumatic disorders.

References

  1. Azurity Pharmaceuticals, Inc. announces FDA approval of Fleqsuvy ™ (baclofen oral suspension). News release. February 7, 2022. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-fleqsuvy-baclofen-oral-suspension-301476187.html
  2. Fleqsuvy. Package insert. Azurity Pharmaceuticals; 2022. Accessed February 7, 2022. https://azurity.com/wp-content/uploads/2022/02/FLEQSUVY-PI-02-04-2022.pdf