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Neurelis announced the availability of Valtoco® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients aged ≥6 years.
Valtoco, a Schedule IV controlled substance, is a ready-to-use nasal spray device available in 5mg, 7.5mg, and 10mg strengths and packaged in doses of 5mg, 10mg, 15mg, and 20mg. Each blister pack contains 1 nasal spray device and each device contains 1 single spray.
Prior to treatment, it is recommended that individuals administering the product be instructed on how to identify seizure clusters and how to use the product appropriately. Dosage for Valtoco is dependent on a patient’s age and weight; it is recommended that Valtoco be used to treat no more than 1 episode every 5 days and no more than 5 episodes per month.
The efficacy of Valtoco was supported by a bioavailability study in healthy adults where diazepam exposure was evaluated following administration of Valtoco nasal spray and diazepam rectal gel. Pharmacokinetic parameters were found to be 2 to 4-fold less variable for Valtoco and within range of those seen with diazepam rectal gel. In addition, a 12-month, open-label, repeat-dose safety study showed that the nasal spray was well tolerated in patients with epilepsy who have frequent breakthrough seizures.
Valtoco carries a Boxed Warning regarding the risks associated with concomitant opioid use (ie, sedation, respiratory depression, coma, death). The most common adverse reactions associated with Valtoco use include somnolence, headache, and nasal discomfort.
Additionally, the Company is offering copay and patient assistance programs to help eligible patients with costs. Maxor Specialty Pharmacy has been selected as the national pharmacy provider and has already begun filling patient prescriptions. “Working with Maxor allows us to expedite the availability of Valtoco for patients, healthcare providers and care partners who need it in advance of Valtoco availability in retail pharmacies in the near future,” said Chuck DeWildt, Chief Commercial Officer at Neurelis.
For more information visit valtoco.com.
