Neuroscience company Neurelis Inc announced on Tuesday that it received the US Food and Drug Administration (FDA) extended expiration dating for its lead product spray VALTOCO for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity ( seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and paediatric patients six years of age and older.
In conjunction with the approval, the US FDA has awarded the company's VALTOCO (diazepam nasal spray) with seven years of Orphan Drug Exclusivity. VALTOCO's intranasal route of administration is reportedly clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam).
In the US, there are more than 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Of these uncontrolled patients, as many as 170,000 are at risk for episodes of frequent seizure activity.
VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail. Intravail transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated and more than 4,000 seizures were treated, concluded the company.
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