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Lyvispah FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 25, 2021.

FDA Approved: Yes (First approved November 22, 2021)
Brand name: Lyvispah
Generic name: baclofen
Dosage form: Oral Granules
Company: Saol Therapeutics, Inc.
Treatment for: Spasticity

Lyvispah (baclofen) is an oral granule formulation of the approved gamma-aminobutyric acid agonist baclofen indicated for the treatment of spasticity.

  • Lyvispah is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patient with spinal cord injuries and other spinal cord diseases. Lyvispah is NOT indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
  • The mechanism of action of baclofen is not fully understood, but it is thought to act on the spinal cord nerves to decrease muscle spasms.
  • Lyvispah granules are administered orally up to four times a day.
  • Common adverse reactions include drowsiness, dizziness, and weakness.

Development timeline for Lyvispah

DateArticle
Dec  7, 2021Approval FDA Approves Lyvispah (baclofen) Oral Granules for the Treatment of Spasticity

Further information

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