Welcome!

Microsoft Cloud Authors: Kevin Benedict, Pat Romanski, Liz McMillan, Lori MacVittie, Elizabeth White

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.

IoT & Smart Cities Stories
A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to great conferences, helping you discover new conferences and increase your return on investment.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of 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. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
Founded in 2000, Chetu Inc. is a global provider of customized software development solutions and IT staff augmentation services for software technology providers. By providing clients with unparalleled niche technology expertise and industry experience, Chetu has become the premiere long-term, back-end software development partner for start-ups, SMBs, and Fortune 500 companies. Chetu is headquartered in Plantation, Florida, with thirteen offices throughout the U.S. and abroad.
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...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER gives detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPOalso offers sp...