Welcome!

Microsoft Cloud Authors: Janakiram MSV, Yeshim Deniz, David H Deans, Andreas Grabner, Stackify Blog

News Feed Item

All Wales Strategic Medical Group and Scottish Medicines Consortium Accept use of Inovelon® (rufinamide) Drinkable, Child-friendly Formulation

HATFIELD, England, November 6, 2012 /PRNewswire/ --

 

New option provides choice for children and young people with Lennox-Gastaut syndrome,

 a severe form of epilepsy

The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines Consortium (SMC) has accepted the use of Inovelon® (rufinamide) oral suspension for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly debilitating form of epilepsy, in children four years and older in Wales and Scotland. The AWSMG and SMC have restricted its use to patients who have failed treatment with, or are intolerant of, other antiepileptic drugs.[1],[2]

The AWSMG and SMC's decision to accept the use of rufinamide oral suspension follows their approval of the tablet formulation in 2008 based on data showing that it can significantly reduce the frequency of total and tonic-atonic seizures, and significantly improve seizure severity, when compared to placebo in patients with LGS.[3] The oral suspension was shown to be bioequivalent and cause minimal budget impact in Scotland and Wales, and was therefore subsequently approved following an abbreviated submission. Many patients who receive the orphan drug rufinamide are children and this new formulation has been developed as a child-friendly, orange-flavoured drinkable liquid to aid the administration of treatment.

"As some children find tablets difficult to swallow, there is a strong need for drinkable medicines especially when treating younger LGS patients," said Helen Cross, Head of Neuroscience Unit, University College London, Institute of Child Health. "Access to the suspension formulation of rufinamide may potentially help young people adhere better to treatment and ultimately may lead to improved outcomes in the management of this severe and highly debilitating disease."

LGS is a severe, rare form of epilepsy accounting for five percent of all cases and rising to approximately 10 percent of childhood epilepsy cases.[4] The annual incidence of the condition affects up to 2.8 per 10,000 births in Europe.[4] Treatment adherence is key to effective LGS management in children as the disease is characterised by multiple daily seizures, mental retardation and regression.[5]

"The AWSMG and SMC's approval of the new drinkable form of rufinamide is important as it may help address the adherence needs of children and young people with this severe form of epilepsy," said Mike Bee, Epilepsy Business Unit Director, EU North. "These approvals are in line with our on-going commitment to the therapeutic area of epilepsy and exemplifies our drive to increase the benefits our medicines provide patients and their families through Eisai's human health care (hhc) mission."

The oral suspension is dose equivalent to the currently marketed rufinamide tablet on a milligram per milligram basis. The AWSMG and SMC approval for the use of the oral suspension follows launches of the medicine in the UK, The Netherlands and Germany. Other European countries will launch the new formulation later this year.

Rufinamide oral suspension received positive CHMP opinion in September 2011 and formal EMA approval was granted in November 2011. The preparation was approved by the FDA and launched in the US in March 2011 (rufinamide is marketed as BANZEL® in the US).  

- ENDS -

About Inovelon® (rufinamide)

Rufinamide is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). It is believed to regulate the activity of sodium channels in the brain which carry excessive electrical charges. The agent was approved for adjunctive therapy for LGS in Europe (under the brand name Inovelon) in 2007.[3] Rufinamide is available as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide. It is available in some countries as an oral suspension in orange flavour 40mg/ml concentration.

The film-coated formulation of rufinamide was first launched in Europe in May 2007 and is now available in 19 European countries.

About Lennox-Gastaut Syndrome

LGS is a debilitating form of childhood-onset epilepsy that most often appears between the ages of two and seven years. It is characterised by frequent and multiple seizure types, and is often accompanied by mental retardation, and psychological and behavioural problems.[6]

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people with the condition worldwide, 10.5 million of which are children under the age of 15.[7],[8],[9] In Scotland it affects nearly 40,000 people.[10]

Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.[11]

About Eisai Europe in Epilepsy

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  • Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
  • Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older

About Eisai:

Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

Eisai concentrates its R&D activities in three key areas:

  • Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
  • Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.

For further information please visit our web site http://www.eisai.com.

References

1. Scottish Medicines Consortium. Inovelon product update. http://www.scottishmedicines.org.uk/files/advice/rufinamide_Inovelon_ABBREVIATED_June_2012_for_website.pdf.  Last accessed 3 September 2012

2. All Wales Strategic Medicines Group. Inovelon product update.
http://www.wales.nhs.uk/sites3/Documents/371/rufinamide%20%28Inovelon%29%20FAR.pdf. Last accessed 2 November 2012

3. Inovelon tablets Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/20165/SPC/. (Accessed January 2012)

4. Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatr Dis Treat. 2008 December; 4(6): 1001-1019.

5. MedScape references Lennox-Gastaut Syndrome http://emedicine.medscape.com/article/1176735-overview (Accessed February 2012)

6. International Journal of Pharma and Bio Sciences. http://www.ijpbs.net/issue-3/82.pdf (Accessed February 2012)

7. Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004. 21-25

8. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233

9. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed February 2012)

10. Epilepsy Scotland available at: http://www.epilepsyscotland.org.uk/ (Accessed 01 November 2010).

11. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed February 2012)

Date of preparation: November 2012
Job code: Inovelon-UK2271

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.

@ThingsExpo Stories
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
It is of utmost importance for the future success of WebRTC to ensure that interoperability is operational between web browsers and any WebRTC-compliant client. To be guaranteed as operational and effective, interoperability must be tested extensively by establishing WebRTC data and media connections between different web browsers running on different devices and operating systems. In his session at WebRTC Summit at @ThingsExpo, Dr. Alex Gouaillard, CEO and Founder of CoSMo Software, presented ...
WebRTC is great technology to build your own communication tools. It will be even more exciting experience it with advanced devices, such as a 360 Camera, 360 microphone, and a depth sensor camera. In his session at @ThingsExpo, Masashi Ganeko, a manager at INFOCOM Corporation, introduced two experimental projects from his team and what they learned from them. "Shotoku Tamago" uses the robot audition software HARK to track speakers in 360 video of a remote party. "Virtual Teleport" uses a multip...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
SYS-CON Events announced today that Evatronix will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Evatronix SA offers comprehensive solutions in the design and implementation of electronic systems, in CAD / CAM deployment, and also is a designer and manufacturer of advanced 3D scanners for professional applications.
Leading companies, from the Global Fortune 500 to the smallest companies, are adopting hybrid cloud as the path to business advantage. Hybrid cloud depends on cloud services and on-premises infrastructure working in unison. Successful implementations require new levels of data mobility, enabled by an automated and seamless flow across on-premises and cloud resources. In his general session at 21st Cloud Expo, Greg Tevis, an IBM Storage Software Technical Strategist and Customer Solution Architec...
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
An increasing number of companies are creating products that combine data with analytical capabilities. Running interactive queries on Big Data requires complex architectures to store and query data effectively, typically involving data streams, an choosing efficient file format/database and multiple independent systems that are tied together through custom-engineered pipelines. In his session at @BigDataExpo at @ThingsExpo, Tomer Levi, a senior software engineer at Intel’s Advanced Analytics gr...
When talking IoT we often focus on the devices, the sensors, the hardware itself. The new smart appliances, the new smart or self-driving cars (which are amalgamations of many ‘things’). When we are looking at the world of IoT, we should take a step back, look at the big picture. What value are these devices providing? IoT is not about the devices, it’s about the data consumed and generated. The devices are tools, mechanisms, conduits. In his session at Internet of Things at Cloud Expo | DXWor...