Amneal is unveiling two generic products.
The company is offering Lyvispah, a baclofen oral granules specialty product approved by the Food and Drug Administration for the treatment of spasticity related to multiple sclerosis and other spinal cord disorders.
Lyvispah is the generic to oral baclofen tablets that provides flexible, customized dosing with 5 mg, 10 mg and 20 mg single-dose packets of granules, the company said.
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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, Amneal noted.
“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” said Chirag and Chintu Patel, co-CEOs. “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.”
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.
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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 spasms 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 such services as free home delivery, Amneal said.
Baclofen has a market value of $130 million for the 12 months ending March 2022, according to IQVIA.