Vigafyde FDA Approval History
Last updated by Judith Stewart, BPharm on June 18, 2024.
FDA Approved: Yes (First approved June 17, 2024)
Brand name: Vigafyde
Generic name: vigabatrin
Dosage form: Oral Solution
Company: Pyros Pharmaceuticals, Inc.
Treatment for: Infantile Spasms
Vigafyde (vigabatrin) is a ready-to-use oral solution formulation of the approved anti-seizure medicine vigabatrin used for the treatment of infantile spasms.
- Vigafyde is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
- Vigabatrin was first approved in 2009 in tablet and powder for oral solution dosage forms under the brand name Sabril. Vigafyde is the first approved oral solution formulation for vigabatrin. It is a clear, colorless to light yellow, peppermint-flavored solution containing vigabatrin 100 mg/mL.
- Infantile spasms is a rare, severe form of epilepsy that can progress to long-term permanent issues such as continued seizures, other forms of epilepsy, autism spectrum disorder, and developmental issues. It typically begins in children who are less than one year of age,
- Vigabatrin works in the treatment of infantile spasms by inhibiting the enzyme GABA transaminase, consequently increasing gamma-aminobutyric acid (GABA) levels in the brain which is thought to enhance seizure control for patients by modulating neuronal excitability.
- Vigafyde is administered orally, usually two times each day. It is important to note that Vigafyde (100 mg/mL) is more concentrated than vigabatrin solutions that are prepared from powder (50 mg/mL).
- Vigafyde carries a Boxed Warning for permanent vision loss and monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended. Vigafyde is available only through a restricted program called the Vigabatrin REMS.
- Warnings and precautions associated with Vigafyde include abnormal MRI signal changes and intramyelinic edema, withdrawal seizures, and anemia.
- Common adverse reactions include somnolence, bronchitis, ear infection, and acute otitis media.
Development timeline for Vigafyde
| Date | Article |
|---|---|
| Jun 17, 2024 | Approval FDA Approves Vigafyde (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution |
Further information
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