FDA Approves Lyvispah for Treatment of Spasticity Resulting From MS

The FDA has approved baclofen (Lyvispah, Saol Therapeutics) oral granules for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Lyvispah may also help patients with spinal cord injuries and other spinal cord diseases.

Lyvispah is a dissolvable, strawberry-flavored granular formulation of baclofen and will be available for patients aged 12 years and older in 5-, 10-, and 20-mg packets. Unlike other formulations of baclofen, it is approved for administration with enteral feeding tubes, with or without water, and with soft foods.

Patients suffering from spasticity may concurrently develop swallowing difficulties. Nearly 1 million people in the United States live with MS, and the prevalence of spasticity within this patient population has been estimated to be as high as 67%, according to a company statement.

Additionally, the prevalence of dysphagia in individuals with MS has been reported to be between 34% and 43%, with aspiration pneumonia frequently cited as a contributing factor in deaths of these patients,the company said.

“Clinicians stressed to us that there is a need for new formulations designed to benefit their patients who have difficulty swallowing. I'm incredibly proud of the work our team has done to get this approved, and our hope is that this is the first in the line of many new therapies we can bring to market to support health care providers and the patients they treat," David Penake, CEO of Saol, said in a statement.

Following this approval, Saol is preparing for a full commercial launch in 2022.

The most common adverse reactions in patients treated with baclofen for spasticity are confusion, constipation, dizziness, drowsiness, fatigue, headache, hypotension, insomnia, nausea, urinary frequency, and weakness.

It is not indicated for the treatment of skeletal muscle spasms resulting from rheumatic disorders. Baclofen is contradicted for those who are hypersensitive to the drug.

Additionally, Saol said that Kamada Ltd will acquire 4 of its plasma-derived hyperimmune products. These include Cytogam (Cytomegalovirus Immune Globulin Intravenous [Human]), indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the heart, liver, lung, kidney, and pancreas; Hepagam B, a hepatitis B Immune Globulin (Human) product indicated to prevent hepatitis B virus recurrence following liver transplantation in hepatitis B surface antigen-positive patients and provide post-exposure prophylaxis; Varizig [Varicella Zoster Immune Globulin (Human)], indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women; and Winrho SDF, a Rho(D) Immune Globulin Intravenous (Human), indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomies, adults with chronic immune thrombocytopenia (ITP),children and adults with ITP secondary to HIV infection, and Rho(D)-positive children with acute or chronic (ITP).

"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 SIL-1002 for Spasticity, SIL-1009 for pyruvate dehydrogenase complex disorder, and SIL-1010 for chronic pain associated with osteoarthritis,” Penake said.

Under the agreement, Kamada will pay Saol up to $160 million, with $95 million upfront, and up to an additional $50 million in sales milestones during 2022 to 2034.

Reference

Saol Therapeutics announces FDA approval of LYVISPAH™ (baclofen) oral granules and the divesture of its plasma-derived hyperimmune portfolio. PR Newswire. News release. December 7, 2021. Accessed December 8, 2021. Email.