Emerging Data on USL261 (Intranasal Midazolam) to Be Presented at the 66th Annual Meeting of the American Epilepsy Society

MAPLE GROVE, Minn., Nov. 26, 2012 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith) a privately held, specialty pharmaceutical company committed to the development of new treatments for diseases of the central nervous system, is proud to sponsor emerging data on USL261, its novel formulation of intranasal midazolam, at the 66^th Annual Meeting of the American Epilepsy Society (AES) in San Diego, CA, November 30 – December 4, 2012.

"Upsher-Smith is committed to working toward improving the lives of people living with epilepsy," said Pamela J. Davis, M.D., Sr. Director Medical Affairs, Medical Strategy, Upsher-Smith.  "USL261 (midazolam) is being developed for the intranasal rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters.  This is a condition where few treatment options presently exist, particularly for the outpatient setting."

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 without active inhalation by the patient. 

Upsher-Smith plans to sponsor presentations for three investigational drug programs in epilepsy at the AES annual meeting.  Following is a guide to Upsher-Smith-sponsored presentations during the meeting.  To schedule an interview with an investigator, please contact Elizabeth Likly at [email protected].

Upsher-Smith-Sponsored Posters

1. Safety and Pharmacodynamics of USL261, a Novel Formulation of Midazolam Optimized for Intranasal Administration, in Subjects with Epilepsy  
Poster 1.366; Poster Session 1, Saturday, December 1, 2012, 11:45 a.m. - 6:00 p.m. (Pacific         Time); Authors Present 11:45 a.m. - 1:45 p.m.

2. Pharmacokinetics of USL261, a Novel Formulation of Intranasal Midazolam Optimized for Intranasal Administration, in Subjects with Epilepsy 
Poster 1.373; Poster Session 1, Saturday, December 1, 2012, 11:45 a.m. - 6:00 p.m. (Pacific         Time); Authors Present 11:45 a.m. - 1:45 p.m.

3. Safety and Pharmacodynamics of USL261, a Novel Formulation of Intranasal Midazolam
Poster Session 3.239; Poster Session 3; Monday, December 3, 2012, 8:00 a.m. - 3:00 p.m. (Pacific Time); Authors Present 12:00 p.m. - 2:00 p.m.

4. Pharmacokinetics of USL261, A Novel Formulation of Intranasal Midazolam
Poster Session 3.238; Poster Session 3; Monday, December 3, 2012, 8:00 a.m. - 3:00 p.m. (Pacific Time); Authors Present 12:00 p.m. - 2:00 p.m.

5. Establishing Maximum Tolerated Dose and Dose-Proportionality in Extended-Release Topiramate (USL255) 
Poster Session 3.233; Poster Session 3; Monday, December 3, 2012, 8:00 a.m. - 3:00 p.m. (Pacific Time); Authors Present 12:00 p.m. - 2:00 p.m.

6. The Preclinical Anticonvulsant Profile of the Novel Investigational Drug Tonabersat
Platform Session A.08; Monday, December 3, 2012, 4:00 p.m. - 6:15 p.m. (Pacific Time)

About Epilepsy
Epilepsy is a medical condition that causes seizures affecting a variety of cognitive and physical functions.  More than two million people in the U.S. are estimated to be affected by epilepsy with about 200,000 new cases of epilepsy diagnosed each year.¹

About Seizure Clusters  
Seizure clusters, also referred to as acute repetitive seizures or increased bouts of seizure activity, are multiple seizures which occur over a relatively brief period of time with a pattern distinguishable from the usual seizure pattern.²  Typically, there is recovery between seizures.³

Reports of seizure cluster prevalence vary, but it has been estimated that approximately 22% of the intractable epilepsy population (approximately 152,000 people) experience them.^4,5,6,7

Seizure emergencies, such as repetitive seizures and seizure clusters, are serious medical events requiring immediate treatment to reduce the risk of morbidity and mortality.^8,9  Inadequate treatment of seizure clusters may 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.^10,11,12  Benzodiazepines are the treatment of choice for management of acute seizures.²  Prehospital treatment with benzodiazepines has been shown to reduce seizure activity significantly compared with seizures that remain untreated until the patient reaches the emergency department; however, currently available options are underused.^2,8,13 It is important to treat  seizure emergencies early for many reasons, including findings that patients treated within 30 minutes of seizure onset are more responsive to first-line treatment.¹⁴

Market research has shown that patients and caregivers would prefer a rescue medication for seizure clusters that could be administered in any setting and that provides effective and rapid seizure termination in an easy-to-use, non-invasive form of administration.¹⁵

Upsher-Smith's Expanding CNS Pipeline 
In addition to USL261, Upsher-Smith's central nervous system pipeline in clinical development includes USL255, an investigational extended-release topiramate for the management of epilepsy in adults, which is being studied in an ongoing international Phase III clinical trial.  Another Upsher-Smith development program involves USL260 (tonabersat), an investigational drug in Phase I of development that is a potential first-in-class neuronal gap junction modulator that is also being explored as a potential treatment for epilepsy.

On August 14, 2012, the company completed its acquisition of UK-based Proximagen Group plc, a European biotechnology company focused on the development and commercialization of novel therapeutics for diseases of the central nervous system and inflammation. 

About Upsher-Smith 
Upsher-Smith, founded in 1919, is an independent and privately-owned specialty pharmaceutical company headquartered in Maple Grove, Minnesota that focuses on product growth and innovation for branded, branded-generic and generic pharmaceuticals.  Upsher-Smith has a particular focus on providing therapies to assist people suffering from central nervous system diseases (including epilepsy, Parkinson's disease and Alzheimer's disease) and also markets products relating to cardiology, dermatology and women's health.  In addition to products currently marketed, Upsher-Smith has an emerging neurology pipeline with three products in clinical development, two of which are in Phase III clinical trials.  For more information, visit www.upsher-smith.com.

References

1. Epilepsy Foundation. About Epilepsy. Available at: http://www.epilepsyfoundation.org/aboutepilepsy.  Accessed October 10, 2012.
2. 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.
3. Cereghino JJ. Identification and treatment of acute repetitive seizures in children and adults. Curr Treat Options Neurol. 2007 Jul;9(4):249-55.
4. 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.
5. Kwan P, Brodie MJ. Early Identification of Refractory Epilepsy. N Engl J Med. 2000;342:314-319.
6. 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.
7. Haut SR, Lipton RB, LeValley AJ, et al. Identifying seizure clusters in patients with epilepsy. Neurology. 2005 October 25;65(8):1313-1315.
8. Cloyd J.  Pharmacologic Considerations in the Treatment of Repetitive or Prolonged Seizures.  Journal of Child Neurology.  2007;22(5 SUPPL.):47S-52S.
9. DeLorenzo RJ, Pellock JM, Towne AR, et al.  Epidemiology of status epilepticus.  J. Clin Neurophysiol.  1995;12:316-325.
10. Haut SR. Seizure clustering. Epilepsy & Behavior. 2006;8:50-55.
11. 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.
12. Epilepsy Foundation. Prolonged or serial seizures (status epilepticus). Available at: http://www.epilepsyfoundation.org/about/types/types/statusepilepticus.cfm. Accessed May 17, 2011.
13. Pellock JM.  Overview: Definitions and Classifications of Seizure Emergencies.  Journal of Child Neurology.  2007;22(5 SUPPL.):9S-13S.
14. Glauser TA. Designing practical evidence-based treatment plans for children with prolonged seizures and status epilepticus. J Child Neurol. 2007;22(5):38S – 46S.
15. Data on File.  Upsher-Smith Laboratories, Inc.  2011.

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SOURCE Upsher-Smith Laboratories, Inc.