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Neurelis Announces 3 Poster Presentations at the 73rd Annual Meeting of the American Academy of Neurology

Neurelis, Inc., will present three posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 at the 73rd Annual Meeting of the American Academy of Neurology (AAN), April 2 to 7, in Seattle, Wash.

These presentations will highlight ease of use, quality of life, and timing of administration of VALTOCO. The full abstracts are available on the AAN meeting website.

VALTOCO, a nasal spray for acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the U.S. Food and Drug Administration (FDA) on Jan. 10, 2020. The AAN posters report the following:

  • Analysis of factors supporting ease of use of diazepam nasal spray. Patient diary entries from the long-term safety study confirmed that treatment administration occurred after seizure onset within a median time of two minutes. The majority of caregivers and patients who self-administered the nasal spray reported that the therapy was either extremely or very easy to use.
  • Results from a patient-reported Quality of Life in Epilepsy (QOLIE) questionnaire among adults with episodes of frequent seizure activity participating in the long-term safety study of diazepam nasal spray. Findings indicated that QOLIE scores were maintained across the 12-month treatment period. Seizure worries and social functioning scores improved during the study.

Additional investigational analysis was done with the following AAN poster reporting:

  • The majority (87%) of treatments in the long-term study used only a single dose over 24 hours. In the instances where a second dose was administered, investigational analysis was performed on the timing of the dose. Second doses administered in less than four hours were not associated with more safety events than those administered after four hours in a clinical trial setting. (VALTOCO prescribing information indicates that a second dose may be given at least 4 hours after the first dose, if needed.)

“Episodes of frequent seizures are emergencies that are associated with an increased risk of progression to status epilepticus, more frequent emergency room visits, and disruption of the daily life and work of both patients and care partners,” said Enrique Carrazana, M.D., Neurelis Chief Medical Officer. “These new abstracts, along with over 60 other presentations at national and international scientific meetings over the past years, add to the increasing clinical evidence of the safety and effectiveness of VALTOCO in treating this patient population.”

In granting VALTOCO Orphan Drug Exclusivity, the FDA recognized its intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (DIASTAT®, a rectal gel formulation of diazepam).

Despite the availability of chronic, daily oral medications to help manage seizures, many of the 50 million epilepsy patients worldwide continue to experience recurring breakthrough seizures that, if left untreated, can cause damage to the brain.

“Our ultimate goal is to improve health outcomes for patients. Reaching this goal requires addressing gaps in seizure treatment and control,” stated Adrian Rabinowicz, M.D., SVP Clinical Development and Medical Affairs. “Our aim is to help healthcare providers and patients develop self or care-partner solutions to stop these challenging episodes of frequent seizures as soon as they start. The availability of a rescue medication that is easy to use, convenient to carry, and socially acceptable for use in public may help patients and their care-partners choose to use rescue therapy instead of relying on hospitalization in the event of a seizure cluster emergency.”

The 12-month Phase 3 study, which evaluated the long-term safety of VALTOCO, included 175 subjects. Out of the total subjects enrolled, there were 163 patients that were dosed; 3,853 seizures were treated with at least one dose of VALTOCO.

Details of a selection of the poster presentations are below and available online to review at the American Academy of Neurology Annual Meeting website.

Additional investigational abstract:

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