|By PR Newswire||
|January 2, 2013 01:00 AM EST||
HATFIELD, England, January 2, 2013 /PRNewswire/ --
Child friendly formulation set to aid administration for the treatment of Lennox-Gastaut syndrome
Inovelon® (rufinamide) oral suspension for adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older is launched today in Spain. As many patients who receive the orphan drug rufinamide are children, the new formulation has been developed as a child friendly 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. In addition, the use of the rufinamide oral suspension allows for individual titration in smaller steps to find the optimal dose for each patient", said Dr. Juan Jose Garcia Peñas, Neuropediatrician at the Hospital Infantil Universitario Niño Jesus. "The availability of the suspension formulation of rufinamide will potentially help young patients adhere better to treatment which should help improve outcomes in the management of this severe and highly debilitating disease."
LGS is a rare form of epilepsy accounting for five percent of all cases and rising to approximately 10 percent of childhood epilepsy cases. The annual incidence of the condition affects about 2.8 per 10,000 births in Europe. Effective LGS management and compliance to treatment is of key importance to children as the condition is characterised by multiple daily seizures, mental retardation and regression.
"The launch of the new drinkable form of rufinamide in Spain will help address the needs of children and young people with this severe form of epilepsy. Improving treatment compliance is a key factor in helping to reduce seizure frequencies, particularly for young people", said Antonio Rodriguez Gallego, Brand Manager EPBU, Eisai Farmaceutica, S.A. "Eisai is working closely with epilepsy centres in Spain to ensure the new treatment is available to patients as soon as possible. This move is entirely in line with our on-going commitment to the therapeutic area of epilepsy and our drive to increase the benefits provided to patients and their families of our medicines through Eisai's human health care (hhc) mission."
The oral suspension is identical in preparation to the currently marketed rufinamide tablet on a milligram per milligram basis. 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).
The development of an oral drinkable suspension formulation of rufinamide demonstrates Eisai's commitment in the therapeutic area of epilepsy and further exemplifies the company's contribution to addressing the diversified needs of and increasing the benefits provided to patients and their families as shown by its human health care (hhc) mission.
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. Inovelon is available as film-coated tablets containing 100mg, 200mg, and 400mg rufinamide.
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.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe. There are an estimated six million people living with epilepsy in Europe and estimated 50 million people worldwide - 10.5 million of which are children under the age of 15.
Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body.
Patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.
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 anti-epileptic drugs (AEDs) is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).
In Europe, Eisai currently has three marketed treatments including:
- Zonegran® (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma). Eisai has applied for the marketing authorisation for zonisamide as monotherapy for newly diagnosed epilepsy patients with partial seizures, with or without second generalisation
- 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 adjunctive treatment, 4 years and older of seizures associated with Lennox-Gastaut Syndrome
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.
1. Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatr Dis Treat. 2008 December; 4(6): 1001-1019.
2. MedScape references Lennox-Gastaut Syndrome http://emedicine.medscape.com/article/1176735-overview (Accessed February 2012)
3. Inovelon tablets Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/20165/SPC/ [http://www.medicines.org.uk/emc/medicine/20165/SPC ] (Accessed January 2012)
4. International Journal of Pharma and Bio Sciences. http://www.ijpbs.net/issue-3/82.pdf (Accessed February 2012)
5. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233
6. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available from; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed February 2011)
7. Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed February 2012)
8. Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004. 21-25
9. 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: January 2013
Job code: Inovelon-UK2277
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 7, 2016 03:30 PM EST Reads: 370
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Feb. 7, 2016 02:45 PM EST Reads: 140
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 7, 2016 02:00 PM EST Reads: 557
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 7, 2016 01:45 PM EST Reads: 361
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 7, 2016 01:30 PM EST
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Feb. 7, 2016 12:00 PM EST Reads: 344
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 7, 2016 11:30 AM EST Reads: 346
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 7, 2016 10:15 AM EST Reads: 108
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 7, 2016 07:00 AM EST Reads: 121
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Feb. 6, 2016 03:30 PM EST Reads: 720
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Feb. 5, 2016 09:00 PM EST Reads: 785
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
Feb. 2, 2016 02:00 PM EST Reads: 412
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Feb. 2, 2016 04:30 AM EST Reads: 851
Learn how IoT, cloud, social networks and last but not least, humans, can be integrated into a seamless integration of cooperative organisms both cybernetic and biological. This has been enabled by recent advances in IoT device capabilities, messaging frameworks, presence and collaboration services, where devices can share information and make independent and human assisted decisions based upon social status from other entities. In his session at @ThingsExpo, Michael Heydt, founder of Seamless...
Feb. 1, 2016 05:00 AM EST Reads: 940
The IoT's basic concept of collecting data from as many sources possible to drive better decision making, create process innovation and realize additional revenue has been in use at large enterprises with deep pockets for decades. So what has changed? In his session at @ThingsExpo, Prasanna Sivaramakrishnan, Solutions Architect at Red Hat, discussed the impact commodity hardware, ubiquitous connectivity, and innovations in open source software are having on the connected universe of people, thi...
Jan. 31, 2016 09:00 PM EST Reads: 726
WebRTC: together these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at WebRTC Summit, Cary Bran, VP of Innovation and New Ventures at Plantronics and PLT Labs, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it may enable, complement or entirely transform.
Jan. 31, 2016 07:15 PM EST Reads: 1,146
There are so many tools and techniques for data analytics that even for a data scientist the choices, possible systems, and even the types of data can be daunting. In his session at @ThingsExpo, Chris Harrold, Global CTO for Big Data Solutions for EMC Corporation, showed how to perform a simple, but meaningful analysis of social sentiment data using freely available tools that take only minutes to download and install. Participants received the download information, scripts, and complete end-t...
Jan. 31, 2016 10:00 AM EST Reads: 1,217
For manufacturers, the Internet of Things (IoT) represents a jumping-off point for innovation, jobs, and revenue creation. But to adequately seize the opportunity, manufacturers must design devices that are interconnected, can continually sense their environment and process huge amounts of data. As a first step, manufacturers must embrace a new product development ecosystem in order to support these products.
Jan. 31, 2016 10:00 AM EST Reads: 812
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, discussed how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the dat...
Jan. 30, 2016 07:45 PM EST Reads: 791
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT’s direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...
Jan. 30, 2016 03:45 PM EST Reads: 1,268