January 14, 2020
The US Food and Drug Administration (FDA) has approved diazepam nasal spray (Valtoco, Neurelis) in patients with epilepsy aged 6 and older for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity such as seizure clusters and acute repetitive seizures that are distinct from a patient's usual seizure pattern.
Valtoco is a proprietary formulation of diazepam incorporating proprietary transmucosal absorption enhancer. It's the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 and older.
"The FDA approval of diazepam nasal spray is a significant advancement for the epilepsy community," R. Edward Hogan, MD, director of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis, Missouri, said in a company news release.
"Until recently, approved treatment outside of medical care settings was only available as a rectally administered medication. The availability of Valtoco may positively impact the lives of thousands of people with epilepsy who experience cluster or acute repetitive seizures, and their care partners," said Hogan.
Diazepam nasal spray was generally safe and well tolerated in a long-term, open-label, repeat dose, clinical trial involving more than 130 patients aged 6 years and older, with more than 2000 seizures treated, the company said.
Valtoco is a ready-to-use nasal spray device available in 5 mg, 7.5 mg, and 10 mg strengths. Dosing is weight- and age-based.
Prior to treatment, healthcare professionals should instruct the individual administering the drug on how to identify seizure clusters and use the product appropriately.
Valtoco is a Schedule IV controlled substance and carries a boxed warning regarding the risks associated with concomitant opioid use, which may result in sedation, respiratory depression, coma, and death. The most common adverse reactions are somnolence, headache, and nasal discomfort.
Neurelis anticipates having Valtoco available for patients in about 2 months.