Saol Therapeutics Announces FDA Approval of LYVISPAH™ (baclofen) Oral Granules and the Divesture of its Plasma-derived Hyperimmune Portfolio

December 7, 2021

ROSWELL, Ga. and DUBLIN and HAMILTON, Bermuda /PRNewswire/ — Saol Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved Saol’s LYVISPAH™ (baclofen) oral granules.

LYVISPAH™ (lye-vis’-pah) 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 patients with spinal cord injuries and other spinal cord diseases.  LYVISPAH™ is a strawberry-flavored, dissolvable granular formulation of baclofen and will be available for patients 12 years and above in 5mg, 10mg, and 20mg packets.  Unlike other formulations of baclofen, it is approved for administration with or without water, with soft foods and with enteral feeding tubes.

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