The Food and Drug Administration (FDA) has approved a diazepam nasal spray (Valtoco; Neurelis, San Diego, CA) as an acute treatment of intermittent stereotypic episodes of frequent seizure activity. The treatment is indicated for seizure clusters and acute repetitive seizures that are distinct from an individual's usual seizure pattern in people with epilepsy age 6 years or more.
Diazepam nasal spray was generally safe and well-tolerated during a long term clinical safety study (NCT02724423). The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.
"Cluster or acute repetitive seizures are challenging to treat and highly disruptive in the lives of people with epilepsy," said Neurelis president and chief executive officer Craig Chambliss. "Valtoco was developed to provide an effective combination of reliability, safety, and tolerability in a ready-to-use nasal spray. This is a defining moment for Neurelis as Valtoco is our first FDA-approved product. We are excited that we can now offer this treatment option to people and provide additional support to the epilepsy community."
The proprietary formulation and delivery mechanism incorporates a transmucosal absorption enhancement technology (Intravail; Neurelis) that enables noninvasive delivery of a broad range of protein, peptide, and small molecule drugs. For those at risk for frequent seizure activity, availability of nasally-delivered acute medication is a great step forward, because until recently, only rectally delivered acute agents were available.
"This is an important development in the epilepsy community," said R. Edward Hogan, MD, director of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis. "Most seizures that require intervention are treated in an inconvenient manner. To be able to reliably treat seizure activity when and where it happens with a caregiver-administered option like Valtoco is a significant step forward. 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."
In the long-term open-label repeat-dose clinical trial (NCT02724423), evaluating safety of diazepam nasal spray was evaluated. More than130 participants were enrolled, and more than 2,000 seizures were treated. The clinical trial included participants age 6 or more. "Until recently, approved treatment outside of medical care settings was only available as a rectally administered medication," Dr. Hogan said. "The FDA approval of diazepam nasal spray is a significant advancement for the epilepsy community."
Michael S. Cartwright, MD, MS, and Hwajin Lee, MD
Jennifer Robblee, MD, MSc; Amaal J. Starling, MD; Rashmi B. Halker Singh, MD, FAHS, FAAN; and Nina Riggins, MD, PhD
Natalia P. Rocha, PharmD, MSc, PhD; Gabriela D. Colpo, PhD; Antonio L. Teixeira, MD, PhD, MSc; and Erin Furr Stimming, MD