SYS-CON MEDIA Authors: Pat Romanski, Esmeralda Swartz, Liz McMillan, AppDynamics Blog, Skytap Blog

News Feed Item

New Data From Upsher-Smith's Epilepsy Portfolio To Be Highlighted At The 66th Annual Meeting Of The American Academy Of Neurology

Upsher-Smith-sponsored data to include the first presentation of pooled Phase 1 data on the adverse event profile of USL255 (Qudexy™ XR (topiramate) extended-release capsules)

MAPLE GROVE, Minn., April 21, 2014 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), will highlight new pooled phase 1 data from studies in healthy adults comparing the adverse event profile of USL255 (Qudexy™ XR) with immediate-release topiramate in a poster presentation at the 66th Annual Meeting of the American Academy of Neurology (AAN) being held April 26 to May 3 in Philadelphia. Upsher-Smith, a fully integrated pharmaceutical company committed to the development of new treatments for diseases of the central nervous system (CNS), will be sponsoring 13 poster presentations at the meeting.

Upsher-Smith Laboratories, Inc.

Qudexy™ XR (topiramate) extended-release capsules, which received Food and Drug Administration approval on March 11, 2014, is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy™ XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures.  It is also approved as adjunctive therapy in patients 2 years of age and older with partial-onset seizures, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.  All strengths of Qudexy™ XR may be swallowed whole or administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of soft food.  This makes it the only approved extended-release topiramate product for patients who experience challenges swallowing whole capsules or tablets.  

"The data being presented at this year's AAN meeting demonstrates Upsher-Smith's ongoing commitment to address the unmet needs of people living with seizure disorders," said Dr. William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith.  "In particular, we look forward to presenting pooled Phase 1 data that further describes Qudexy™ XR's improved tolerability profile with respect to overall and cognitive adverse events compared with immediate-release topiramate."

Following is a guide to Upsher-Smith-sponsored data that will be presented during the AAN annual meeting:

USL255 (Qudexy™ XR (topiramate) extended-release capsules)

USL261 (intranasal midazolam)

INDICATIONS

Qudexy™ XR (topiramate) extended-release capsules is a prescription medicine used:

  • to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 10 years of age and older,
  • with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

IMPORTANT SAFETY INFORMATION

Do not take Qudexy™ XR if you have metabolic acidosis and are also taking metformin (e.g., Glucophage®).

Qudexy XR can cause serious side effects, including: Eye problems. Serious eye problems include blurred vision, sudden decrease in vision with or without eye pain and redness, and a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). Decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Increased acid level in your blood (metabolic acidosis). This may or may not cause symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or trouble thinking clearly. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may harm your baby if you are pregnant. High blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. This has happened when Qudexy XR is taken with a medicine called valproic acid (e.g., Depakene® and Depakote®). Kidney stones.  Drink plenty of fluids when taking Qudexy XR to decrease your chances of getting kidney stones. Low body temperature. Taking Qudexy XR when you are also taking valproic acid may cause a drop in body temperature to less than 95 degrees F, tiredness, confusion, or coma. Effects on thinking and alertness. Qudexy XR may affect how you think, and can cause confusion, and problems with concentration, attention, memory, or speech. Qudexy XR may cause depression or mood problems, tiredness, and sleepiness. Dizziness or loss of muscle coordination. Call your healthcare provider right away if you have any of the above symptoms.

The most common side effects include tingling of the arms and legs (paresthesia), irregular movements of the eyes (nystagmus), loss of appetite, nausea or indigestion, a change in the way foods taste, diarrhea, weight loss, nervousness, and upper respiratory tract infection. These are not all the possible side effects of Qudexy XR. For more information, ask your healthcare provider or pharmacist.

Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Qudexy XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying; have attempted to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, trouble sleeping (insomnia), or new or worsening irritability; feel or act aggressive, angry, or violent; act on dangerous impulses; have an extreme increase in activity and talking (mania); or experience other unusual changes in behavior or mood.

Before taking Qudexy XR, tell your healthcare provider about any other medical conditions, including if you have had depression, mood problems, or suicidal thoughts or behavior; have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or plan to become pregnant; or if you are breastfeeding.  Qudexy XR passes into your breast milk. It is not known if the Qudexy XR that passes into breast milk can harm your baby.  Talk to your healthcare provider about the best way to feed your baby if you take Qudexy XR.

Qudexy XR can harm your unborn baby. All women of childbearing age should talk to their healthcare providers about possible alternative treatments. If you take Qudexy XR during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. If the decision is made to use Qudexy XR, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Qudexy XR.

Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Qudexy XR and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take metformin (e.g., Glucophage®); valproic acid (e.g., Depakene or Depakote); any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills; medicines used to prevent seizures; or any other carbonic anhydrase inhibitors. Qudexy XR may make your birth control pills less effective.

Do not stop Qudexy XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Qudexy XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Qudexy XR slowly.

Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures.

Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision. Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictable seizures.

If you are unable to swallow QUDEXY XR capsules whole, the medicine may be sprinkled on a spoonful of soft food like applesauce. Do not store the food and medicine mixture to use later or crush or chew the food and medicine mixture before swallowing.

This safety information is not all-inclusive. For additional important information, talk to your healthcare provider and read the Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information at www.qudexyxr.com

About Epilepsy
Epilepsy is a medical condition that is characterized by recurrent seizures.  More than two million people in the U.S. are estimated to be affected by epilepsy with about 150,000 new cases of epilepsy diagnosed each year.1  Epilepsy can be associated with profound physical, psychological and social consequences that negatively impact people's lives. 

Upsher-Smith's Epilepsy Pipeline
In addition to the recently-approved Qudexy™ XR, Upsher-Smith's clinical development pipeline includes two investigational drugs that are being studied for the management of seizure disorders.  The pipeline includes USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters, which is the subject of an ongoing international Phase 3 clinical trial (ARTEMIS1) with an open-label safety extension study.  In addition, USL260 (tonabersat) is in early clinical development as a potential first-in-class neuronal gap junction modulator.

About Upsher-Smith
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing pharmaceutical company dedicated to its mission of Advancing Pharmacotherapy. Improving Life™.  With capabilities ranging from early-stage research to delivering on-market products, Upsher-Smith is committed to offering quality products that enable people to live life to its greatest potential.  Upsher-Smith's approach to product development and partnering has resulted in a robust pipeline of promising CNS therapies in various stages of development.  For more information, visit www.upsher-smith.com. For more information about Qudexy™ XR, visit www.qudexyxr.com.

References

1. Epilepsy.com. Available at: http://www.epilepsy.com/learn/epilepsy-statistics.  Accessed April 16, 2014.

Logo - http://photos.prnewswire.com/prnh/20130520/NY17281LOGO

SOURCE Upsher-Smith Laboratories, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
It's time to face reality: "Americans are from Mars, Europeans are from Venus," and in today's increasingly connected world, understanding "inter-planetary" alignments and deviations is mission-critical for cloud. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, discussed cultural expectations of privacy based on new research across these elements
Recurring revenue models are great for driving new business in every market sector, but they are complex and need to be effectively managed to maximize profits. How you handle the range of options for pricing, co-terming and proration will ultimately determine the fate of your bottom line. In his session at 15th Cloud Expo, Brendan O'Brien, Co-founder at Aria Systems, session examined: How time impacts recurring revenue How to effectively handle customer plan changes The range of pricing a...
Mobile, the cloud and data have upended traditional ways of doing business. Agile, continuous delivery and DevOps have stepped in to hasten product development, but one crucial process still hasn't caught up. Continuous content delivery is the missing limb of the success ecosystem. Currently workers spend countless, non-value add hours working in independent silos, hunting for versions, manually pushing documents between platforms, all while trying to manage the continuous update and flow of mul...
Over the last few years the healthcare ecosystem has revolved around innovations in Electronic Health Record (HER) based systems. This evolution has helped us achieve much desired interoperability. Now the focus is shifting to other equally important aspects - scalability and performance. While applying cloud computing environments to the EHR systems, a special consideration needs to be given to the cloud enablement of Veterans Health Information Systems and Technology Architecture (VistA), i.e....
"At Harbinger we do products as well as services. Our services are with helping companies move their products to the cloud operating systems. Some of the challenges we have seen as far as cloud adoption goes are in the cloud security space," noted Shrikant Pattathil, Executive Vice President at Harbinger Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
After a couple of false starts, cloud-based desktop solutions are picking up steam, driven by trends such as BYOD and pervasive high-speed connectivity. In his session at 15th Cloud Expo, Seth Bostock, CEO of IndependenceIT, cut through the hype and the acronyms, and discussed the emergence of full-featured cloud workspaces that do for the desktop what cloud infrastructure did for the server. He also discussed VDI vs DaaS, implementation strategies and evaluation criteria.
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP ...
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Bring the world's best IaaS to the world's best PaaS. In their session at 15th Cloud Expo, Animesh Singh, a Senior Cloud Architect and Strategist for IBM Cloud Labs, and Jason Anderson, a Cloud Architect for IBM Cloud Labs, shared their experiences running Cloud Foundry on OpenStack. They focused on how Cloud Foundry and OpenStack complement each other, how they technically integrate using cloud provider interface (CPI), how we could automate an OpenStack setup for Cloud Foundry deployments, an...
"Application monitoring and intelligence can smooth the path in a DevOps environment. In a DevOps environment you see constant change. If you are trying to monitor things in a constantly changing environment, you're going to spend a lot of your job fixing your monitoring," explained Todd Rader, Solutions Architect at AppDynamics, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"Desktop as a Service is emerging as a very big trend. One of the big influencers of this – for Esri – is that we have a large user base that uses virtualization and they are looking at Desktop as a Service right now," explained John Meza, Product Engineer at Esri, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
More and more file-based and machine generated data is being created every day causing exponential data and content growth, and creating a management nightmare for IT managers. What data centers really need to cope with this growth is a purpose-built tiered archive appliance that enables users to establish a single storage target for all of their applications - an appliance that will intelligently place and move data to and between storage tiers based on user-defined policies. In her session a...
IBM has announced a new strategic technology services agreement with Anthem, Inc., a health benefits company in the U.S. IBM has been selected to provide operational services for Anthem's mainframe and data center server and storage infrastructure for the next five years. Among the benefits of the relationship, Anthem has the ability to leverage IBM Cloud solutions that will help increase the ease, availability and speed of adding infrastructure to support new business requirements.
CodeFutures has announced Dan Lynn as its new CEO. Lynn assumes the role from Founder Cory Isaacson, who has joined RMS and will now serve as chairman of CodeFutures. Lynn brings more than 14 years of advanced technology and business success experience, and will help CodeFutures build on its industry leadership around its Agile Big Data initiatives. His technical expertise will be invaluable in advancing CodeFutures’ AgilData platform and new processes for streamlining and gaining value from gro...