FDA approves first nasal spray for cluster seizures

The United States Food and Drug Administration (FDA) approved diazepam nasal spray (Valtoco, Neurelis) in patients with epilepsy of 6 years or more for the acute treatment of intermittent stereotypic episodes of frequent seizure activity, such as seizure groups and acute repetitive seizures that are different from a patient’s usual seizure pattern.

Valtoco is a patented diazepam formulation that incorporates a patented transmucosal absorption enhancer. It is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy 6 years and older.

“The FDA’s approval of diazepam nasal spray is a significant advance for the epilepsy community,” Dr. R. Edward Hogan, MD, director of the University of Washington and the Center, said in a press release from the company. of Jewish Epilepsy Barnes in St. Louis, Missouri.

“Until recently, approved treatment outside of healthcare settings was only available as a medication administered rectally. The availability of Valtoco can positively impact the lives of thousands of people with epilepsy experiencing acute or group repetitive seizures. , and his care partners, “he said. Hogan

Diazepam nasal spray was generally safe and well tolerated in a long-term, open-label, repeated-dose clinical trial, involving more than 130 patients 6 years of age and older, with more than 2000 seizures treated, the company said. .

Valtoco is a ready-to-use nasal spray device available in doses of 5 mg, 7.5 mg and 10 mg. The dosage is based on weight and age.

Before treatment, health professionals should instruct the person administering the medication on how to identify seizure groups and use the product properly.

Valtoco is a controlled substance in Schedule IV and contains a warning box on the risks associated with the concomitant use of opioids, which can cause sedation, respiratory depression, coma and death. The most common adverse reactions are drowsiness, headache and nasal discomfort.

Full prescription information and a medication guide are available online.

Neurelis expects to have Valtoco available for patients in approximately 2 months.

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