January 13, 2020

The U.S. FDA has approved Valtoco® (diazepam nasal spray), manufactured by Neurelis Pharmaceuticals, to provide acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in individuals who are at least six years of age and have been diagnosed with epilepsy.

An estimated 3.4 million people in the United States have epilepsy, a neurological disorder characterized by seizure activity. Although daily maintenance therapies for epilepsy are available, many patients continue to experience seizures while on treatment. Up to 170,000 of these patients are at risk of episodes of frequent seizure activity, which can have a significant impact on their health and quality of life.

In clinical studies, Valtoco was found to be safe and well-tolerated in patients who experience frequent seizure activity. Its pharmacokinetic parameters (drug absorption, distribution, metabolism, and excretion from the body) were also less variable than diazepam rectal gel, a current standard of care. Valtoco uses a proprietary Intravail® formulation designed to provide consistent and reliable absorption of the medication through nasal passage mucous membranes. With its intranasal delivery system, Valtoco may also be easier for caregivers to administer at home than rectal gel diazepam formulations.

Recommended dosing varies based on the patient’s weight and age. If an initial dose is insufficient to treat a seizure episode, a second dose can be administered at least four hours after the first. No more than two doses should be used to treat a single episode. Valtoco should not be used to treat more than one episode every five days and more than five episodes per month. A black box warning cautions that the use of benzodiazepines like diazepam in conjunction with opioids increases the risk of profound sedation, respiratory depression, coma, and death.

Valtoco is available at a wholesale acquisition cost (WAC) of $560 per box. Each box contains two single-use blister packs containing one dose each.

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