What is Lyvispah (baclofen) for?

Lyvispah (baclofen) is a gamma-aminobutyric acid (GABA) agonist indicated for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.^[1]

Lyvispah may also be beneficial in patients with spinal cord injuries and other spinal cord diseases. It is not indicated for the treatment of skeletal muscle spasms resulting from rheumatic disorders.^[1]

It is available as oral granules, containing either 5, 10 or 20 mg baclofen.^[1]

How does Lyvispah (baclofen) work?

The active ingredient in Lyvispah, baclofen, is used to help relax certain muscles in your body. It helps relieve spasticity (cramping, and tightness of muscles) caused by conditions such as MS or certain injuries to the spine. It can also reduce pain and improve muscle movement.^[2]

How baclofen works is not fully understood. Baclofen works on the central nervous system (CNS) to relax the muscles. Baclofen is a derivative of the neurotransmitter gamma- aminobutyric acid (GABA). GABA is a naturally occurring chemical that blocks certain brain signals and decreases activity in your nervous system. GABA can bind to a protein in your brain known as a GABA receptor, producing a calming effect on muscles.^[3]

Where has Lyvispah (baclofen) been approved?

Lyvispah (baclofen) was approved for the treatment of spasticity resulting from MS by:

• The Food and Drug Administration on December 7, 2021.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Lyvispah (baclofen) taken?

The standard dosage is:^[1]

• Starting dose: initiate treatment with a low dosage, preferably in divided doses. Increase gradually based on clinical response and tolerability
• The maximum dosage is 80 mg daily (20 mg four times a day)

Lyvispah can be administered by mouth; the granules will dissolve in the mouth or can be swallowed. Additionally, the drug can be mixed with liquid or soft foods and can also be administered via a feeding tube.^[1]

Slowly reduce the dose of Lyvispah when you discontinue treatment. This helps minimize the risk of adverse reactions. In case of serious adverse reactions, treatment can be stopped rapidly.^[1]

Complete information about Lyvispah (baclofen) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Lyvispah?

Common adverse reactions

The most common adverse reactions (≥15% of patients) listed in the prescribing information include:^[1]

• Drowsiness
• Dizziness
• Weakness

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Risk of symptoms from stopping Lyvispah, such as severe muscle problems, organ failure, and death
• Withdrawal symptoms in infants
• Drowsiness and sedation
• Increase in symptoms of mental illness
• Sudden increase in high blood pressure (autonomic dysreflexia)
• Decrease in seizure control
• Changes in posture and balance
• Ovarian cysts (fluid filled sac on ovary)

Use in a specific population

It is not known if Lyvispah can harm your unborn baby. Lyvispah should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Baclofen has been shown to pass into milk in low levels. This would not be expected to cause any adverse effects in your baby, especially if the child is older than 2 months.^[1]

Withdrawal symptoms can occur in breastfed children when maternal administration of Lyvispah is stopped, or when breastfeeding is stopped.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Lyvispah (baclofen) [PDF]
Saol Therapeutics, Dec 2021

2. Baclofen
Mayoclinic.org, cited Mar 2022

3. What Does Gamma Aminobutyric Acid (GABA) Do?
Healthline.com, cited Mar 2022

4. Saol Therapeutics Announces FDA Approval of LYVISPAH™ (baclofen) Oral Granules and the Divesture of its Plasma-derived Hyperimmune Portfolio
Press release, Dec 2021