Therapy Areas: Central Nervous System
Amneal Launches Lyvispah for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders
2 June 2022 - - US-based Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has undertaken the commercial launch of Lyvispah, a baclofen oral granules (5, 10 and 20 mg) specialty product approved by the US Food and Drug Administration for the treatment of spasticity related to multiple sclerosis and other spinal cord disorders, the company said.

Lyvispah is 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.

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, US annual sales for baclofen for the 12 months ended March 2022 were USD 130m.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, New Jersey, is a fully integrated essential medicines company.

In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs.

Through its AvKARE segment, the company is a distributor of pharmaceuticals and other products for the US federal government, retail, and institutional markets.
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