SAN DIEGO, CA — April 4, 2022 — 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 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.)
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).
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.
The original website link: