Lyvispah Oral Granules Approved for Spasticity Due to Multiple Sclerosis

The Food and Drug Administration (FDA) has approved 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.

The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah. The pharmacokinetic studies demonstrated similar bioavailability for the 20mg dose of baclofen oral granules and oral tablets under fasting conditions.

Lyvispah oral granules may be administered directly into the mouth; the granules will dissolve in the mouth or can be swallowed. Additionally, the product can be mixed with liquid or soft foods prior to administration. 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 may also be given via enteral feeding tube.

The most common adverse reactions reported with Lyvispah were drowsiness, dizziness, and weakness.


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The product is supplied as a strawberry-flavored, dissolvable granular formulation of baclofen in 5mg, 10mg, and 20mg packets. It is expected to be available in 2022. 

“Lyvispah represents an important treatment option for individuals with spasticity who have dysphagia, said Dr Michael Saulino, Chair of Physical Medicine and Rehabilitation at Cooper University Hospital. “The bioequivalence between Lyvispah and traditional oral baclofen products should allow for straightforward prescribing by clinicians who manage patients with both clinical problems.”

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

References

  1. Saol Therapeutics announces FDA approval of Lyvispah™ (baclofen) oral granules and the divesture of its plasma-derived hyperimmune portfolio. News release. Saol Therapeutics. Accessed December 7, 2021. https://www.prnewswire.com/news-releases/saol-therapeutics-announces-fda-approval-of-lyvispah-baclofen-oral-granules-and-the-divesture-of-its-plasma-derived-hyperimmune-portfolio-301439556.html
  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.

Source: Medical Bag https://www.medicalbag.com/home/news/lyvispah-oral-granules-approved-for-spasticity-due-to-multiple-sclerosis/

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