Diazepam Nasal Spray Available for Seizure Cluster Rescue
The spray is the first nasal spray treatment for seizure cluster rescue.
Diazepam nasal spray (Valtoco, Neurelis) is commercially available for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in adult and pediatric patients aged 6 years and older. The spray is the first nasal spray treatment for seizure cluster rescue, according to the company.
Officials with the FDA approved diazepam nasal spray on January 10, 2020, recognizing the spray’s intranasal route of administration as clinically superior to the previously approved standard of care treatment.
Diazepam nasal spray uses Intravail® transmucosal absorption enhancement technology to enable the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. More than 4000 seizures were treated in a long-term, open-label clinical trial, which included adult and pediatric patients aged 6 years and older.
The most common adverse reactions reported from the clinical trial included somnolence, headache, and nasal discomfort. Other serious adverse reactions include glaucoma, central nervous system depression, and suicidal behavior and ideation.
In an effort to support patients, Neurelis is offering a diazepam nasal spray copay assistance program through which eligible patients could pay a minimum of $20 for the prescription. A patient assistance program for patients who do not have insurance was also set up by the company.
Neurelis announces commercial availability of Valtoco® (diazepam nasal spray) for seizure cluster rescue [news release]. San Diego, CA; Neurelis: March 10, 2020 [email]. Accessed March 16, 2020.