Pharma Focus Asia

Amneal Launches LYVISPAH® (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders

Thursday, June 02, 2022

Amneal Pharmaceuticals, Inc., announced the commercial launch of LYVISPAH®, a baclofen oral granules (5, 10 and 20 mg) specialty product approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of spasticity related to multiple sclerosis and other spinal cord disorders.

LYVISPAHis bioequivalent to oral baclofen tablets and provides flexible, customized dosing with 5mg, 10mg and 20mg single-dose packets of granules. The rapidly dissolving flavored granules provide an alternative for patients with spasticity who also have difficulty swallowing pills. The product can be administered three ways: poured directly into the patient’s mouth with or without water, mixed with liquids or foods, or through an enteral feeding tube.

“This is the first Specialty product launch for the business since Rytary® (carbidopa and levodopa) in 2015, and the first in a cadence of new branded launches planned over the next several years. The launch of LYVISPAH is the next step in our strategy to expand our Specialty business and drive accelerated growth. As we build our position in the neurology space, we see a clear need for more options to treat spasticity resulting from multiple sclerosis and other spinal cord disorders based on individual patient’s needs. We believe LYVISPAH provides that option,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

In January, Amneal announced the acquisition of Saol Therapeutics’ baclofen franchise and the expansion of its neurology presence into spasticity with LYVISPAH and Lioresal® (baclofen), a baclofen product delivered through an implantable intrathecal pump for use in the management of severe spasticity of cerebral or spinal origin for the institutional market.

Baclofen, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries. It was first approved by the FDA in 1977. The FDA-approved labeling says that LYVISPAH oral granules are indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity, and may also be of some value in patients with spinal cord injuries and other spinal cord diseases. LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

LYVISPAH will be available through both specialty and retail channels upon launch, with a full patient support program. The Company has partnered with BlinkRx, a patient access company, to support patients on LYVISPAH with services, such as free home delivery.

According to IQVIA®, U.S. annual sales for baclofen for the 12 months ended March 2022 were $130 million.

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