Lyvispah, Dissolvable Form of Baclofen, Now Available in US

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by Marta Figueiredo, PhD |

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Lyvispah — a dissolvable granular formulation of baclofen — is now commercially available in the U.S. for adults and adolescents, 12 and older, with spasticity associated with multiple sclerosis (MS) and other spinal cord disorders.

In people with MS, the strawberry-flavored formulation is particularly suitable to ease flexor spasticity and associated pain, muscular rigidity, and repetitive, involuntary up and down muscle movements. Flexor spasticity is the involuntary bending of the knees and hips toward the chest, which can be painful and incapacitating.

“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,” Chirag and Chintu Patel, the co-CEOs of Amneal Pharmaceuticals, which will market the therapy, said in a press release. “We believe Lyvispah provides that option,” they added.

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Lyvispah will be available through both specialty and retail channels, with a full patient support program, created in collaboration with BlinkRx, that will help patients with certain services, such as free home delivery of the therapy.

Baclofen (sold as Lioresal, among other generic brand names) is a muscle relaxant used to treat spasms and stiffness caused by MS, and spinal cord injuries. It was available previously for delivery only through a spinal canal injection or oral tablets.

Developed by Saol Therapeutics, now part of Amneal, Lyvispah is a bioequivalent to oral baclofen tablets, meaning that the two medications provide the same amount of the active ingredient at the proper site of action.

Its rapidly dissolving granules — available in packets of 5, 10, and 20 milligrams (mg) for more flexible dosing — provide a more convenient option for patients who also experience difficulties in swallowing pills.

This is particularly relevant for people with MS, as swallowing difficulties are estimated to affect 34–43% of these patients. Unlike other formulations of baclofen, Lyvispah can be taken with or without water, mixed with liquids or foods, and through an enteral feeding tube, which allows food to be delivered directly into the stomach or small bowel.

The U.S. launch comes about six months after the therapy was approved by the U.S. Food and Drug Administration for use. The decision was based on studies that confirmed Lyvispah-baclofen tablet bioequivalence in healthy adults.

The studies analyzed how much of the active ingredient entered circulation with either formulation and showed that in both forms, peak concentrations were reached about one hour after administration, and these levels dropped to half about 5.5 hours later.

With Saol’s acquisition, Amneal also acquired Lioresal (baclofen intrathecal injection), which comprises a pump implanted into the spinal canal to manage severe spasticity that is available for the institutional market.

 

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