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Valtoco Approval History

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 a benzodiazepine nasal spray for the short-term treatment of epilepsy cluster seizures.

  • 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 6 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 once 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.
  • Diazepam is a Schedule IV controlled substance and can produce drug dependence. 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.
  • The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Development History and FDA Approval Process for Valtoco

DateArticle
Jan 13, 2020Approval FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
Sep 25, 2018Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
Jan  4, 2017Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA
May 20, 2016Acorda to Discontinue Development of Plumiaz (diazepam nasal spray) for Treatment of Epilepsy Seizure Clusters
May  2, 2014FDA Issues Complete Response Letter for Plumiaz (diazepam nasal spray) for Epilepsy Cluster Seizures
Mar 20, 2013Diazepam Nasal Spray Demonstrates Comparable Bioavailability to Diazepam Rectal Gel in Pharmacokinetic Study
Jun 22, 2011Particle Sciences Develops Proprietary Nasal Delivery Formulation Used in Neurelis' Recently Announced Successful Phase I Pharmacokinetic Study of NRL-01 (intranasal diazepam)

Further information

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