MAPLE GROVE, Minn., April 26, 2012 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the launch of http://www.seizureclusterstudy.com, an informational website for individuals diagnosed with partial or generalized epilepsy who experience seizure clusters and are interested in participating in an ongoing Phase III clinical trial. The study, ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) is designed to evaluate the efficacy and safety of USL261, an investigational formulation of midazolam delivered intranasally, for the outpatient rescue treatment of seizure clusters. The website is the first of several planned initiatives to support the epilepsy community's participation in this important clinical trial.
The new website, http://www.seizureclusterstudy.com provides individuals suffering from or diagnosed with epilepsy and their caregivers information about ARTEMIS1 including key eligibility requirements. In addition to the website, interested individuals can call 1-866-372-0526 to learn more or to locate study centers.
"Clinical trials allow for the evaluation of safety and efficacy of investigational medications before they are made available to a broader population," said Pamela J. Davis, M.D., Sr. Director Medical Affairs, Medical Strategy, Upsher-Smith. "Clinical trials are an important part of the process to identify new treatment options for patients living with conditions such as seizure clusters where there is a significant need for new therapies. Upsher-Smith is working closely with the epilepsy community to complete ARTEMIS1 so that findings from the study can be interpreted and incorporated in the New Drug Application for intranasal midazolam."
Added Dr. Davis, "Eligible patients who participate in the ARTEMIS1 trial will receive study drug and office visits at no cost. Patients and caregivers will receive travel reimbursement, and caregivers will receive additional training."
USL261 (midazolam) is a benzodiazepine in an investigational formulation that is delivered intranasally. It is intended to be administered by a caregiver in an outpatient setting for the rescue treatment of seizure clusters. USL261 does not require active inhalation by the patient.
ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray), a Phase III randomized, double-blind, placebo-controlled study, compares USL261 with an intranasal placebo in males and females ages 14 to 65 years. To be eligible for the trial, participants must have a diagnosis of seizure clusters and must have an adult caregiver who can recognize, observe and record seizure cluster episodes and who is willing to be trained in the study procedures, among other criteria. The seizure clusters must have a pattern that is different from the individual's other non-cluster seizure activity and must be recognizable by the caregiver.
The primary objective of the study is treatment success which is defined as termination of seizure(s) after study drug administration and no recurrence of seizure(s) within a specified timeframe after study drug administration. For more information on the study, please visit http://www.clinicaltrials.gov/ct2/show/NCT01390220?term=NCT01390220&rank=1.
USL261 has been granted orphan drug designation for this use by the Food and Drug Administration (FDA). Upsher-Smith owns the exclusive global rights to USL261.
About Seizure Clusters
Seizure clusters, also referred to as acute repetitive seizures, are multiple seizures which occur over a relatively brief period of time with a pattern distinguishable from the usual seizure pattern.(1) Typically, there is recovery between seizures.(2)
Estimates of seizure cluster prevalence vary, but it has been estimated that approximately 22% of the intractable epilepsy population (approximately 152,000 people) experience them.(3,4,5,6)
Inadequate treatment of seizure clusters can potentially impact the safety of an epilepsy patient, may result in emergency room visits, and/or may evolve into status epilepticus, a potentially life-threatening condition.(7,8,9)
Market research has shown that patients and caregivers prefer a rescue medication for seizure clusters that can be administered in any setting, and provides effective and rapid seizure termination in an easy-to-use, non-invasive form of administration.(10)
Epilepsy is a medical condition that causes seizures affecting a variety of cognitive and physical functions. An estimated three million people in the U.S. have some form of epilepsy with about 200,000 new cases of epilepsy diagnosed each year.(11)
Upsher-Smith's Expanding CNS Pipeline
Upsher-Smith's central nervous system (CNS) pipeline includes a number of investigational drug programs. In addition to USL261 (intranasal midazolam), USL is developing USL255 (extended-release topiramate) for the management of epilepsy in adults, which is being studied in an ongoing international Phase III clinical trial (PREVAIL). Another Upsher-Smith development program involves USL260 (tonabersat), an investigational drug and potential first-in-class neuronal gap junction modulator that is also being explored as a potential treatment for epilepsy.
Upsher-Smith Laboratories, Inc. is a privately held, U.S.-based company devoted to improving health and advancing wellness since 1919. Upsher-Smith demonstrates its commitment to meeting the healthcare needs of its customers by developing, producing and marketing consumer and prescription products. In addition to its strong heritage in generics, Upsher-Smith's branded businesses focus on women's health, dermatology and CNS therapeutic areas. For additional information, visit http://www.upsher-smith.com.
(1.) Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998;338:1869-75.
(2.) Cereghino JJ. Identification and treatment of acute repetitive seizures in children and adults. Curr Treat Options Neurol. 2007 Jul;9(4):249-55.
(3.) Kobau R, Zahran H, Thurman DJ, et al. Epilepsy Surveillance Among Adults – 19 States, Behavioral Risk Factor Surveillance System, 2005. MMWR. 2008;57:SS-6.
(4.) Kwan P, Brodie MJ. Early Identification of Refractory Epilepsy. N Engl J Med. 2000;342:314-319.
(5.) Berg AT, Vickrey BG, Testa FM, et al. How long does it take for epilepsy to become intractable? A prospective investigation. Annals of Neurology. 2006;60:73-79.
(6.) Haut SR, Lipton RB, LeValley AJ, et al. Identifying seizure clusters in patients with epilepsy. Neurology. 2005 October 25;65(8):1313-1315.
(7.) Haut SR. Seizure clustering. Epilepsy & Behavior. 2006;8:50-55.
(8.) Mitchell WG. Status epilepticus and acute repetitive seizures in children, adolescents and young adults: etiology, outcome and treatment. Epilepsia. 1996;37(Suppl. 1):S74-80.
(9.) Epilepsy Foundation. Prolonged or serial seizures (status epilepticus). Available at: http://www.epilepsyfoundation.org/about/types/types/statusepilepticus.cfm. Accessed May 17, 2011.
(10.) Upsher-Smith Laboratories, Inc. Epilepsy Patient and Caregiver Insights and Reactions to a New Rescue Medication. March 2011.
(11.) Epilepsy Foundation. Epilepsy and seizure statistics. Available at: http://www.epilepsyfoundation.org/aboutepilepsy/whatisepilepsy/statistics.cfm. Accessed March 26, 2012.
SOURCE Upsher-Smith Laboratories, Inc.