FDA Approves Therapy for Multiple Sclerosis-Related Spasticity

The oral granules formulation allows it to be used with soft foods and with feeding tubes.

The FDA has approved Saol Therapeutics’ Lyvispah (baclofen) oral granules for the treatment of patients 12 years of age or older with spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

It is a strawberry-flavored, dissolvable granular formulation of baclofen and is available 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.

Patients suffering from spasticity may develop swallowing difficulties. Nearly 1 million people in the United States are living with multiple sclerosis, and the prevalence of spasticity within this patient population has been estimated to be as high as 67%. Additionally, the prevalence of swallowing difficulty in the multiple sclerosis population has been reported to be between 34% and 43%.

“Lyvispah represents an important treatment option for individuals with spasticity who have dysphagia. The bioequivalence between Lyvispah and traditional oral baclofen products should allow for straightforward prescribing by clinicians who manage patients with both clinical problems,” Michael Saulino, M.D., Ph.D., chair of physical medicine and rehabilitation at Cooper University Hospital, said in a statement.

Company officials expect full commercial launch in 2022.