|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
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
May. 25, 2015 12:00 PM EDT Reads: 4,041
SYS-CON Events announced today that DragonGlass, an enterprise search platform, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. After eleven years of designing and building custom applications, OpenCrowd has launched DragonGlass, a cloud-based platform that enables the development of search-based applications. These are a new breed of applications that utilize a search index as their backbone for data...
May. 25, 2015 12:00 PM EDT Reads: 1,716
T-Mobile has been transforming the wireless industry with its “Uncarrier” initiatives. Today as T-Mobile’s IT organization works to transform itself in a like manner, technical foundations built over the last couple of years are now key to their drive for more Agile delivery practices. In his session at DevOps Summit, Martin Krienke, Sr Development Manager at T-Mobile, will discuss where they started their Continuous Delivery journey, where they are today, and where they are going in an effort ...
May. 25, 2015 12:00 PM EDT Reads: 1,114
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
May. 25, 2015 12:00 PM EDT Reads: 1,247
Container frameworks, such as Docker, provide a variety of benefits, including density of deployment across infrastructure, convenience for application developers to push updates with low operational hand-holding, and a fairly well-defined deployment workflow that can be orchestrated. Container frameworks also enable a DevOps approach to application development by cleanly separating concerns between operations and development teams. But running multi-container, multi-server apps with containers ...
May. 25, 2015 12:00 PM EDT Reads: 1,776
Software Development Solution category in The 2015 American Business Awards, and will ultimately be a Gold, Silver, or Bronze Stevie® Award winner in the program. More than 3,300 nominations from organizations of all sizes and in virtually every industry were submitted this year for consideration. "We are honored to be recognized as a leader in the software development industry by the Stevie Awards judges," said Steve Brodie, CEO of Electric Cloud. "We introduced ElectricFlow and our Deploy app...
May. 25, 2015 12:00 PM EDT Reads: 1,574
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
May. 25, 2015 11:30 AM EDT Reads: 3,443
Gartner predicts that the bulk of new IT spending by 2016 will be for cloud platforms and applications and that nearly half of large enterprises will have cloud deployments by the end of 2017. The benefits of the cloud may be clear for applications that can tolerate brief periods of downtime, but for critical applications like SQL Server, Oracle and SAP, companies need a strategy for HA and DR protection. While traditional SAN-based clusters are not possible in these environments, SANless cluste...
May. 25, 2015 11:00 AM EDT Reads: 1,417
Software Defined Storage provides many benefits for customers including agility, flexibility, faster adoption of new technology and cost effectiveness. However, for IT organizations it can be challenging and complex to build your Enterprise Grade Storage from software. In his session at Cloud Expo, Paul Turner, CMO at Cloudian, looked at the new Original Design Manufacturer (ODM) market and how it is changing the storage world. Now Software Defined Storage companies can build Enterprise grade ...
May. 25, 2015 11:00 AM EDT Reads: 4,445
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists will address the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affec...
May. 25, 2015 11:00 AM EDT Reads: 1,249
SYS-CON Events announced today that EnterpriseDB (EDB), the leading worldwide provider of enterprise-class Postgres products and database compatibility solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. EDB is the largest provider of Postgres software and services that provides enterprise-class performance and scalability and the open source freedom to divert budget from more costly traditiona...
May. 25, 2015 11:00 AM EDT Reads: 1,448
Fundamentally, SDN is still mostly about network plumbing. While plumbing may be useful to tinker with, what you can do with your plumbing is far more intriguing. A rigid interpretation of SDN confines it to Layers 2 and 3, and that's reasonable. But SDN opens opportunities for novel constructions in Layers 4 to 7 that solve real operational problems in data centers. "Data center," in fact, might become anachronistic - data is everywhere, constantly on the move, seemingly always overflowing. Net...
May. 25, 2015 11:00 AM EDT Reads: 4,731
To manage complex web services with lots of calls to the cloud, many businesses have invested in Application Performance Management (APM) and Network Performance Management (NPM) tools. Together APM and NPM tools are essential aids in improving a business's infrastructure required to support an effective web experience... but they are missing a critical component - Internet visibility. Internet connectivity has always played a role in customer access to web presence, but in the past few years u...
May. 25, 2015 10:00 AM EDT Reads: 5,505
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
May. 25, 2015 10:00 AM EDT Reads: 3,969
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists will peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud en...
May. 25, 2015 10:00 AM EDT Reads: 1,713