Amneal has announced the launch of Lyvispah® (baclofen) oral granules for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. The gamma-aminobutyric acid agonist may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Lyvispah is bioequivalent to oral baclofen tablets. The rapidly dissolving granules can be administered in 3 ways: poured directly into the patient’s mouth with or without water, mixed with liquids or soft foods (eg, applesauce, yogurt, or pudding), or through an enteral feeding tube. The mixture should be administered no more than 2 hours after mixing.

The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah. Bioavailability does not appear to be affected by water or applesauce; however, pharmacokinetic data show that administering with a high fat meal resulted in a 10% decrease in AUC and 29% decrease in Cmax compared with the fasted state. 

Lyvispah is supplied as a strawberry-flavored, dissolvable granular formulation of baclofen in 5mg, 10mg, and 20mg packets. The product is available through both specialty and retail channels.

Lyvispah is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

References

  1. Amneal launches Lyvispah® (baclofen) for spasticity related to multiple sclerosis and other spinal cord disorders. News release. Amneal Pharmaceuticals, Inc. Accessed June 1, 2022. https://www.businesswire.com/news/home/20220601005309/en/Amneal-Launches-LYVISPAH%C2%AE-baclofen-for-Spasticity-Related-to-Multiple-Sclerosis-and-Other-Spinal-Cord-Disorders
  2. Lyvispah. Package insert. Saol Therapeutics; 2021. Accessed December 7, 2021. https://lyvispah.com/content/uploads/2021/11/LYVISPAH-USPI-NOVEMBER-2021-FDA-approved.pdf