FDA Approves Lyvispah, Granular Form of Baclofen, to Treat Spasticity
The U.S. Food and Drug Administration (FDA) has approved Lyvispah, a dissolvable granular formulation of baclofen, to treat spasticity in people with multiple sclerosis (MS).
The strawberry-flavored formulation, developed by Saol Therapeutics, is particularly suitable to ease flexor spasticity, the involuntary bending of the knees and hips toward the chest, which can be painful and incapacitating. It also may ease spasticity in people with spinal cord injuries or other disorders involving the spinal cord.
“We are tremendously excited by the approval of Lyvispah,” David Penake, CEO of Saol Therapeutics, said in a press release. “Spasticity is a challenging condition to treat, and we have commonly heard that no two patients are alike. Because of this, clinicians stressed to us that there is a need for new formulations designed to benefit their patients who have difficulty swallowing.”
Lyvispah will be available to patients 12 years and older in packets of 5, 10, and 20 milligrams (mg). According to the company, a full commercial launch is expected in 2022. The maximum daily dose is 80 mg, or 20 mg four times a day.
Unlike other formulations of baclofen, Lyvispah can be taken with or without water, with soft foods, and with enteral nutrition — when food is delivered via a tube directly into the stomach or small bowel. This is particularly important for the 34% to 43% of MS patients estimated to have difficulty swallowing, or dysphagia.
Baclofen is a muscle relaxant used to treat muscle spasms and stiffness caused by multiple sclerosis and spinal cord injuries. Sold as Lioresal, among other generic brand names, the treatment was formerly available for delivery only via a spinal canal injection or in a tablet formulation.
However, spinal injections are painful and sometimes associated with side effects, and tablets are often not suitable for people who have trouble swallowing, a problem that commonly affects those with spasticity.
The approval of Saol’s granular formulation of baclofen was based on studies in healthy adults that compared how much of the active ingredient entered circulation with Lyvispah versus with the tablet formulation of baclofen.
Results showed a similar bioavailability with both forms, with peak concentrations being reached about one hour after administration, and levels dropping to half of peak about 5.5 hours later.
“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,” said Michael Saulino, MD, chair of physical medicine and rehabilitation at Cooper University Hospital in New Jersey.
The company also announced that is has sold four of its plasma-derived hyperimmune products for a total of up to $160 million. Proceeds will be used to commercialize Lyvispah and advance the development of other therapies.
“The proceeds from the sale of the hyperimmune products will be invested to expand our commercial infrastructure to launch Lyvispah and further development of our pipeline assets,” Penake said.
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