VALTOCO Granted Orphan Drug Exclusivity by the FDA

| By | FDA Approved
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Neurelis, Inc., 13 January, announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an 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 people with epilepsy 6 years of age and older. The unique formulation of VALTOCO incorporates Intravail® for consistent and reliable absorption.

“Cluster or acute repetitive seizures are challenging to treat and highly disruptive in the lives of people with epilepsy,” said Neurelis President and CEO 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 patients and provide additional support to the epilepsy community.”

Chambliss added that VALTOCO was also granted seven years of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development.

VALTOCO is a proprietary formulation of diazepam incorporating the Science of Intravail. Intravail transmucosal absorption enhancement technology enables the non-invasive 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: over 130 patients were enrolled and more than 2,000 seizures were treated. The clinical trial included patients aged 6 and above.

“Until recently, approved treatment outside of medical care settings was only available as a rectally administered medication,” said R. Edward Hogan, MD, Director of the Washington University and Barnes-Jewish Epilepsy Center in St. Louis. “The FDA approval of diazepam nasal spray is a significant advancement for the epilepsy community.”

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