Navigation Links
Upsher-Smith Announces Patient Enrollment In Open-label Safety Study Of USL261 (Intranasal Midazolam) For Rescue Treatment Of Seizure Clusters In Epilepsy
Date:6/24/2013

tment of seizure clusters.  We are pleased to offer eligible patients access to USL261 during this study period as this will help to inform the safety profile of the product."

"Seizure emergencies, such as repetitive seizures and seizure clusters, are serious medical events requiring immediate treatment to reduce the risk of morbidity and mortality," said Robert T. Wechsler, MD, PhD, FAAN, Medical Director, Idaho Comprehensive Epilepsy Center.  "There is a significant need for new therapies to treat seizure clusters.  Currently, only one medication is FDA-approved for intermittent bouts of increased seizure activity outside of the hospital setting, and it must be delivered rectally, which may be undesirable to some individuals."

Favorable Phase I data for USL261 in healthy volunteers were recently presented at the Annual Meeting of the American Academy of Neurology in March 2013.  The results demonstrated that peak midazolam plasma concentrations were rapidly achieved (10-15 min) after dosing with USL261.  USL261 also demonstrated increased absorption with an improved bioavailability compared to an equivalent dose of injectable midazolam delivered intranasally.  Single doses of USL261 up to 7.5 mg were generally well tolerated.     

About ARTEMIS1
ARTEMIS1, a Phase III randomized, double-blind, placebo-controlled study, is designed to assess the efficacy, safety and tolerability of USL261 in males and females ages 14 to 65 years with seizure clusters.  Study medication is administered intranasally without active inhalation by the patient.

The primary efficacy endpoint of the study is Treatment Success, which is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) within four hours after study drug administration.

To be eligible for t
'/>"/>

SOURCE Upsher-Smith Laboratories, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Upsher-Smith Is Honored With Prestigious Industry Award For Leadership And Innovation
2. Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures
3. Upsher-Smith Introduces Newly Redesigned Corporate Website
4. Upsher-Smith Presents Data Supporting Favorable Tolerability And Consistent Pharmacokinetic Profile Of Once-Daily USL255 (Extended-Release Topiramate)
5. Emerging Data From Upsher-Smiths CNS Portfolio Highlighted At 2013 American Academy Of Neurology Meeting
6. Doug Zitnak of Upsher-Smith Laboratories Named Small Brand Manufacturer Representative of the Year By Cardinal Health
7. Tina Fehr, Senior Product Manager For AmLactin, Upsher-Smith Laboratories Named PM360 Trailblazer Winner For Womens Health Brand Manager
8. Upsher-Smith Teams Up With Epilepsy Foundation of Minnesota for 2012 Stroll for Epilepsy
9. Upsher-Smith Is Honored with Prestigious Industry Award for Excellence and Innovation
10. Dave Zitnak Of Upsher-Smith Laboratories Named Branded Representative Of The Year By McKesson Corporation
11. Upsher-Smith Research Shows Unique Pharmacokinetic Profile of USL255 Extended Release Topiramate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Aug. 29, 2014 Pomerantz LLP has filed ... the "Company") (NASDAQ: EDAP ) and certain ... States District Court, Southern District of New ... behalf of a class consisting of all persons or ... and July 30, 2014, inclusive (the "Class Period"). This class ...
(Date:8/29/2014)... , Aug. 29, 2014 Thoratec Corporation (NASDAQ: ... mechanical circulatory support therapies to save, support and restore ... the 2014 Morgan Stanley Global Healthcare Conference on Wednesday, ... President and Chief Executive Officer, will provide an update ... Time (9:55 a.m., Pacific Daylight Time).   ...
(Date:8/29/2014)... DUBLIN , Aug. 29, 2014 Research ... CNS Disorders Drug Pipeline Insight 2014" report to their ... market in US is one of the largest segments of ... an alarming rate, while the available therapies were unable to ... growth in the market for CNS disorder, especially over the ...
Breaking Medicine Technology:SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3US CNS Disorders Drug Pipeline Insight 2014 2
... Sept. 21, 2011 Boehringer Ingelheim,s investigational tyrosine kinase ... reducing lung function decline in patients with idiopathic pulmonary ... published today online in the New England Journal ... progressive and severely debilitating lung disease with a high ...
... CHAPEL HILL, N.C., Sept. 21, 2011 Pharmaceutical ... support a variety of product-related initiatives, from treatment ... playing such a pivotal role in a product,s ... use of Health Outcomes data. To ...
Cached Medicine Technology:New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis 2New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis 3New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis 4New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis 5Optimizing the Use of Health Outcomes Data in the Marketplace 2
(Date:8/30/2014)... Daily Gossip magazine reveals in its "Panic Away" ... under control with a simple and efficient method. , ... new method as an anxiety recovery program which promises ... anxiety related disorders. , What makes this program ... can be accessed by users from the comfort of ...
(Date:8/30/2014)... Scotch Plains, NJ (PRWEB) August 30, 2014 ... the first facilities in New Jersey and even in ... in-demand technology that takes inches off of patients’ waists ... by freezing cells in small sections, Vanquish is more ... without pain. Patients lay comfortably under panels about ...
(Date:8/30/2014)... Delhi, India (PRWEB) August 30, 2014 ... introduced low cost SEO service for small businesses. , ... or start-ups cannot afford costly search engine optimization service. ... budget of small businesses into account. , On ... said, “We have introduced this low cost SEO service ...
(Date:8/30/2014)... 30, 2014 The establishment and ... has been one of the main strategies of ... a positive impact around the world. , Architecturally ... top trained executives and trainers deliver L. Ron ... Vital statistics demonstrate that significant reduction in ...
(Date:8/30/2014)... Acne is a common problem millions of American cope with ... a daily nuisance, for some, it can have a crippling impact ... lead to dramatic mood swings and depression. , Those struggling ... their skin. In some cases, that can make the problem even ... those on a quest for clearer skin can now view ...
Breaking Medicine News(10 mins):Health News:Panic Away Review Reveals New Natural Remedy for Anxiety Patients 2Health News:NJ Top Docs Presents, The Plastic Surgery Group 2Health News:RBSEO Services Introduces Low Cost SEO Service for Small Businesses 2Health News:Cradle of Aviation Museum Opens Its Doors to Long Island Scientologists 2Health News:Acne Treatment Reviews Added to Popular Treatment Website 2
... first study of its kind, 161 postnatal women with ... groups to test the effect of a physiotherapist-led exercise ... group received an eight-week "Mother and Baby" program, including ... with parenting education. In the second group, ...
... University of Delaware have developed a new method for ... other diseases., Developed by Zhihao Zhuang, UD assistant professor ... chemical method yields hundredsfold more ubiquitylated proteins than current ... such mysteries as how cancer cells gain resistance to ...
... ... technology with the launch of their new web based clinical Label Approval System - ... ... continue to showcase innovative technology with the launch of their new web based clinical ...
... is available in <A HREF=",http://chinese.eurekalert.org/zh/emb_releases/2010-04/aaoo-amb032510.php,">Chinese . ... where very thin needles are used to stimulate ... therapeutic responses, may be an effective treatment option ... olfactory dysfunction (PVOD), according to new research in ...
... and unemployment rates that are nearly double that of ... to make less use of public assistance, especially childcare ... Policy Program. OSU researchers Deana Grobe and Bobbie ... Minnesota, found that the rates of use of such ...
... than one in four elderly Americans lacked the capacity to make ... to a study of 3,746 people to be published April 1 ... who had advance directives - including living wills or durable powers ... of the time, says lead author Maria Silveira, M.D., M.P.H., physician ...
Cached Medicine News:Health News:New mums beat the blues and increase wellbeing with physio exercise, study reveals 2Health News:UD team develops new method for producing proteins critical to medical research 2Health News:Almac to Improve Label Approval Process in Clinical Trials 2Health News:Almac to Improve Label Approval Process in Clinical Trials 3Health News:Acupuncture may be an effective treatment for post-viral infection loss of smell 2Health News:Despite much-higher poverty rates, rural Oregonians use less public assistance 2Health News:Despite much-higher poverty rates, rural Oregonians use less public assistance 3Health News:More than one-quarter of elderly patients lack decision-making capacity at death 2Health News:More than one-quarter of elderly patients lack decision-making capacity at death 3
... Pipette Tracker Pro is the only pipette calibration ... regulated environment with the tools that they need ... All of the features of Pipette Tracker ... Full audit trail implementation Support for Oracle ...
... V-shaped bottom allows easy withdrawal of ... per bag, ,• Corner pouring lips ... Basin designed for 4, 8, and 12 ... bottom permits withdrawal of practically all of ...
Reservoir, High Profile, Multi Well, 12 Row, Pyramid Bottom, 21mL Available Sterile...
Reservoir, High Profile, Single Well, 96ch-format, Pyramid Bottom, 240mL Available Sterile...
Medicine Products: