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U.S. FDA Approves Oral Formulations of Baclofen for MS-Related Muscle Spasticity: Lyvispah™ and Fleqsuvy™ Now Available

July 11, 2022

The U.S. Food and Drug Administration approved two new oral formulations of baclofen, a muscle relaxant for the treatment of spasticity (spasms, cramping, and extreme tightness of muscles) in people with multiple sclerosis ages 12 and older. Lyvispah™ (Amneal Pharmaceuticals LLC) and Fleqsuvy™ (Azurity Pharmaceuticals), described separately below, are now available.
 
Baclofen acts on the central nervous system to relieve spasticity. It also improves muscle movement and relieves pain from spasticity. Other forms of baclofen include injections and tablets.
 
Lyvispah
Lyvispah is a strawberry-flavored, dissolvable granular formulation of baclofen and will be available in 5mg, 10mg, and 20mg packets.  It is approved for administration with or without water, with soft foods and with enteral feeding tubes.
 
The FDA approval of Lyvispah is based on studies in healthy adults that compared it to baclofen tablets. The most common side effects of Lyvispah include drowsiness, dizziness, and weakness. Other cautions include:
  • Baclofen should be reduced gradually when discontinuing use, because abrupt discontinuation has resulted in serious adverse reactions including death
  • Individuals should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them.
  • The central nervous system effects of Lyvispah may be additive to those of alcohol and other depressants (substances that affect the central nervous system, slowing down the messages between the brain and the body).
  • Lyvispah can worsen psychotic disorders, autonomic dysreflexia, and epilepsy.
View the full prescribing information here.
 
Lyvispah is available at most local pharmacies. Amneal has partnered with BlinkRx, a patient access company, to support people on Lyvispah  with services, such as free home delivery. For additional questions, contact BlinkRx at 1-833-984-2820.
 
Fleqsuvy
Fleqsuvy is a concentrated, grape-flavored liquid formulation of baclofen. It will be available in 120-ml or 300-ml bottles at a concentration of 5 mg per ml.
 
The FDA approval of Fleqsuvy is based on studies in healthy adults that compared it to baclofen tablets. The most common side effects of Fleqsuvy include drowsiness, dizziness, and weakness. Other cautions include:
  • Baclofen should be reduced gradually when discontinuing use, because abrupt discontinuation has resulted in serious adverse reactions including death
  • Individuals should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them.
  • The central nervous system effects of Fleqsuvy may be additive to those of alcohol and other depressants (substances that affect the central nervous system, slowing down the messages between the brain and the body).
  • Fleqsuvy can worsen psychotic disorders, autonomic dysreflexia, and epilepsy.
View the full prescribing information here.
 
Fleqsuvy is available at most pharmacies within 24 hours and can be accessed by mail. Azurity offers a patient support program at https://azuritysolutions.com/, which offers co-pay savings for eligible people with commercial insurance, and additional income-based financial help for people without insurance.
 
Fleqsuvy is a trademark of Azurity Pharmaceuticals, Inc.
Lyvispah is a trademark of Amneal Pharmaceuticals LLC

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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