Navigation Links
Upsher-Smith Laboratories Adds ITI-111 (Nasal Midazolam) to CNS Development Pipeline
Date:6/28/2010

MAPLE GROVE, Minn., June 28 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced an agreement with Ikano Therapeutics, Inc. to obtain exclusive global rights to ITI-111, Ikano's nasal midazolam.  Under terms of the agreement, Upsher-Smith will assume all further development, testing and clinical study of nasal midazolam as an orphan drug for the management of acute repetitive seizure (ARS) in patients with epilepsy.  Upon successful completion of development and regulatory approval, Upsher-Smith will commercialize the product, initially in the U.S. market.

"Currently, epilepsy patients experiencing cluster seizures or acute repetitive seizures have limited options for treatment," said Dr. Jacqueline French, Professor of Neurology at the New York University Comprehensive Epilepsy Center.  "A product such as nasal midazolam could represent an additional treatment option for these patients, and has the potential to address a significant unmet need."

Some patients with epilepsy periodically experience episodes of ARS that are distinct from their usual seizure pattern.  There have been no new FDA-approved products targeting ARS in nearly 15 years.(1)

"The addition of nasal midazolam to our growing development portfolio represents a significant milestone in helping us achieve our vision of building a leadership position in the central nervous system field," said Mark Evenstad, President of Upsher-Smith.  "We will continue to focus our efforts on the development of products that address significant unmet needs for patients with epilepsy, Parkinson's disease and Alzheimer's disease."

Upsher-Smith's development programs for the management of epilepsy include USL255 (extended-release topiramate) and tonabersat.  USL255 is an internally developed program that recently entered a Phase III clinical trial for the adjunctive treatment of partial onset seizures in adults.  USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available immediate-release topiramate options. Tonabersat is a first-in-class neuronal gap junction modulator that may have applicability in a variety of neurological conditions, including migraine and epilepsy.

About Epilepsy and Acute Repetitive Seizures (ARS)

Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions.

ARS may be defined as a predictable component of a patient's seizure disorder which is historically distinct from the patient's other seizures in type, frequency, severity or duration with an onset which is easily recognized by the patient's family and physician.(2)  An ARS episode may last from minutes to hours and may have a consistent, predictable component such as an aura or prodrome which is temporally linked to subsequent seizures.  Episodes of ARS may progress to prolonged seizure or status epilepticus in some patients and may diminish the function and quality of life for both patients and their families.(2)

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that manufactures and markets branded and branded generic prescription and over-the-counter products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and central nervous system diseases.  The company's growing CNS pipeline concentrates on diseases with significant unmet need, including epilepsy, Parkinson's disease, and Alzheimer's disease.  Its leading CNS products in development are USL255 (extended-release topiramate) and tonabersat for epilepsy, and PRX1 for the symptomatic treatment of Parkinson's disease.  To expand its CNS pipeline, Upsher-Smith seeks alliances and co-development programs, pursues licensing and acquisitions, and leverages the development of its core competency in formulation development.  For more information, visit www.upsher-smith.com.

About Ikano Therapeutics Inc.

Ikano Therapeutics Inc. (ITI) is a specialty pharmaceutical company focused on developing innovative specialty therapeutics, with an emphasis on drugs in areas for which there is proven, unsatisfied medical and patient need. ITI's goal is to apply formulation and development expertise across selected therapeutic areas to create new and differentiated products that improve safety, efficacy and clinical utility for patients, caregivers and health care professionals. For more information, please visit the ITI web site at http://www.ikanotherapeutics.com.

1. Martin J. Acute repetitive seizures and seizure emergencies: weighing your treatment options. March 3, 2005. Accessed 6/1/10 at www.epilepsy.com/articles/ar_1109872672.

2. Cereghino JJ. Identification and treatment of acute repetitive seizures in children and adults. Curr Treat Options Neurol. 2007 Jul; 9(4):249-55.


'/>"/>
SOURCE Upsher-Smith Laboratories, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Upsher-Smith Announces New Formulation of PreNexa(R) Prenatal Vitamins
2. New Data: Cholesterol Management Analysis of Upsher-Smiths Slo-Niacin(R) Tablets in Combination with Lipitor(R)
3. Upsher-Smith Announces Milestone in Development of CNS Strategy
4. Upsher-Smith Introduces New Formulation of PreNexa® Prenatal Vitamins
5. Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
6. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
7. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
8. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
9. Romark Laboratories Raises $18 Million in Institutional Financing
10. Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
11. Romark Laboratories Initiates Phase II Study of Nitazoxanide in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Newborns are highly vulnerable to infections ... their young immune systems typically mount weak antibody ... achieving strong vaccine responses in newborn animals, including ... trials — by adding compounds known as adjuvants ... papers, they also describe improved adjuvant formulations that ...
(Date:3/23/2017)... LONDON , March 23, 2017 ... efficacy from the TACTI-mel trial of IMP321 in combination ... in the first (1mg/kg) cohort experiencing a complete response. ... final cohort is expected to be fully recruited by ... of the AIPAC breast cancer study are expected mid-year ...
(Date:3/23/2017)... March 23, 2017 ... Enterprises Limited, gibt die Ernennung von Stuart ... bietet seinen globalen Pharmazeutikkunden eine einmalige integrierte ... wichtige Rolle für das erfolgreiche Wachstum und ... Leiter wird Herr Needleman dafür verantwortlich sein, ...
Breaking Medicine Technology:
(Date:3/23/2017)... Houston, Texas (PRWEB) , ... March 23, 2017 , ... ... their 3rd location in the greater Houston Area. The new location is located at ... St. Luke’s Hospital in Springwoods Village. This newest location will provide patients living in ...
(Date:3/23/2017)... ... March 23, 2017 , ... The IoT (Internet of Things) is revolutionizing ... a huge impact on businesses and individual consumers alike. Laboratories can maximize their ... a value anywhere from $4 trillion to $11 trillion dollars by the year 2025. ...
(Date:3/23/2017)... ... March 23, 2017 , ... March is National Kidney Month – the ... it comes to maintaining good health. Every day, two kidneys filter about 120 to ... drop of your blood, eliminating waste, regulating fluid levels and blood pressure, supporting bone ...
(Date:3/23/2017)... ... 2017 , ... The Wound Certification Prep Course (WCPC) ... LLC, today announced that RestorixHealth® has officially endorsed WCPC as its ... in becoming Certified Wound Specialist Physicians (CWSP®). , This collaborative effort with ...
(Date:3/23/2017)... ... March 23, 2017 , ... After raising more than ... , the most-funded travel pillow in crowdfunding history, has established a U.S. ... wildly popular travel innovation to Americans. , “We’re excited to be operating on U.S. ...
Breaking Medicine News(10 mins):