Valtoco FDA Approval History
Last updated by Judith Stewart, BPharm on April 17, 2025.
FDA Approved: Yes (First approved January 10, 2020)
Brand name: Valtoco
Generic name: diazepam
Dosage form: Nasal Spray
Company: Neurelis, Inc.
Treatment for: Epilepsy
Valtoco (diazepam) is an immediate-use benzodiazepine nasal spray for the short-term treatment of seizure clusters in patients with epilepsy.
- Valtoco is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.
- Valtoco is a ready-to-use, single-dose nasal spray device. A dose is administered as a single spray intranasally into one nostril. Higher doses may require two nasal spray devices, with one spray administered into each nostril. A second dose, when required, may be administered at least 4 hours after the initial dose. No more than 2 doses should be administered to treat a single episode. It is recommended that Valtoco be used to treat no more than one episode every five days and no more than five episodes per month.
- Diazepam is a Schedule IV controlled substance which means it has a low potential for abuse and a low risk of dependence. Valtoco comes with a Boxed Warning for the risks of concomitant use with opioids; risks of abuse, misuse, and addiction; and dependence and withdrawal reactions if used more frequently than recommended.
- Common adverse reactions (at least 4%) include somnolence, headache, and nasal discomfort.
Development timeline for Valtoco
Further information
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