The Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray; Neurelis) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, 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.
The efficacy of Valtoco, a benzodiazepine, was supported by a bioavailability study in healthy adults where diazepam exposure was evaluated following administration of Valtoco nasal spray and diazepam rectal gel. Pharmacokinetic parameters were found to be 2 to 4-fold less variable for Valtoco and within range of those seen with diazepam rectal gel. In addition, a 12-month, open-label, repeat-dose safety study showed that the nasal spray was well tolerated in patients with epilepsy who have frequent breakthrough seizures.
Valtoco is a Schedule IV controlled substance and carries a Boxed Warning regarding the risks associated with concomitant opioid use (ie, sedation, respiratory depression, coma, death). The most common adverse reactions associated with Valtoco use include somnolence, headache, and nasal discomfort.
Valtoco is a ready-to-use nasal spray device available in 5mg, 7.5mg, and 10mg strengths and packaged in doses of 5mg, 10mg, 15mg, and 20mg. Prior to treatment, it is recommended that individuals administering the product be instructed on how to identify seizure clusters and how to use the product appropriately. Dosing recommendations for Valtoco are based on a patient’s age and weight; it is recommended that Valtoco be used to treat no more than 1 episode every 5 days and no more than 5 episodes per month.
Neurelis anticipates having Valtoco available for patients in approximately 60 days.
For more information visit valtoco.com.
This article originally appeared on MPR