MAPLE GROVE, Minn., July 18, 2011 /PRNewswire/ — Upsher-Smith
Laboratories, Inc. announced today the initiation of a Phase III
clinical trial to evaluate the safety and efficacy of USL261, an
investigational intranasal midazolam, for the rescue treatment of
seizures in patients on stable anti-epileptic drug (AED) regimens
who require control of intermittent bouts of increased seizure
activity, frequently referred to as seizure clusters. USL261 has
been granted orphan drug designation for this use by the Food and
Drug Administration (FDA).
The Phase III randomized, double-blind, placebo-controlled
study, ARTEMIS1 [“Acute Rescue Therapy in Epilepsy with Midazolam
Intranasal Spray”], will compare intranasal midazolam, a
benzodiazepine, with an intranasal placebo in males and females
ages 14 to 65 years with a diagnosis of seizure clusters and who
have a competent caregiver. The seizure clusters must have a
pattern that is different from the individual’s other non-cluster
seizure activity and must be recognizable by a caregiver. USL261
may allow a caregiver to deliver an appropriate dose of the
medication intranasally to an individual who is experiencing an
intermittent bout of increased seizure activity. It is intended
that this administration will not require an active inhalation by
the patient.
The trial will enroll eligible patients with partial or
generalized seizures who are on stable AED regimens. USL261 is the
subject of a global Phase III clinical trial (ARTEMIS1), being
conducted under a Special Protocol Assessment (SPA) agreement with
the FDA.
For more information on the study, please visit
http://www.clinicaltrials.gov/ct2/show/NCT01390220?term=NCT01390220&rank=1.
There is a significant need for new therapies to manage
intermittent bouts of increased seizure activity, or seizure
clusters. Currently, only one medication is FDA-appro
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