News Lyvispah, Dissolvable Form of Baclofen, Now Available in US Lyvispah, Dissolvable Form of Baclofen, Now Available in US by Marta Figueiredo, PhD | June 3, 2022 Share this article: Share article via email Copy article link Lyvispah ā a dissolvable granular formulation of baclofen ā is now commercially availableĀ 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. āWe see a clear need for more options to treat spasticity resulting from multiple sclerosis and other spinal cord disorders based on individual patientās needs,ā Chirag and Chintu Patel, the co-CEOs of Amneal Pharmaceuticals, which will market the therapy, said in a press release.Ā āWe believe Lyvispah provides that option,ā they added. Recommended Reading November 17, 2021 by BioNews Staff Expert Voices: Dealing with sex and intimacy issues for people with MS 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 byĀ 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 ā available in packets of 5, 10, and 20 milligrams (mg) for more flexible dosing ā 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 34ā43% 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 Saolās 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. Print This Page About the Author Marta Figueiredo, PhD Marta holds a biology degree, a masterās in evolutionary and developmental biology, and a PhD in biomedical sciences from the University of Lisbon, Portugal. She was awarded a research scholarship and a PhD scholarship, and her research focused on the role of several signaling pathways in thymus and parathyroid glands embryonic development. She also previously worked as an assistant professor of an annual one-week embryology course at the University of Lisbonās Faculty of Medicine. Tags baclofen, bioequivalence, spasticity
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