Click here to close now.

Welcome!

.NET Authors: Dana Gardner, Pat Romanski, Andreas Grabner, Elizabeth White, Tad Anderson

News Feed Item

Se presenta en España la nueva formulación en suspensión oral de Inovelon®(rufinamida)

HATFIELD, Inglaterra, January 2, 2013 /PRNewswire/ --

Formulación de fácil administración apta para niños para el tratamiento del síndrome de Lennox-Gastaut

Hoy se presenta en España Inovelon® (rufinamida) en suspensión oral para el tratamiento coadyuvante (complementario) de las crisis asociadas al síndrome de Lennox-Gastaut (SLG) en niños a partir de cuatro años de edad. Como muchos pacientes que reciben el medicamento subvencionado rufinamida son niños, la nueva formulación se ha desarrollado como un líquido bebible apto para niños para facilitar la administración del tratamiento.

«Como a algunos niños les resulta difícil tragar los comprimidos convencionales, existe una gran necesidad de medicinas bebibles, en especial para tratar a los pacientes de SLG más jóvenes. Además, el uso de rufinamida en suspensión oral permite el ajuste individual de la dosis en pasos más pequeños hasta encontrar la dosis óptima para cada paciente», afirma el Dr. Juan José García Peñas, neuropediatra del Hospital Infantil Universitario Niño Jesús. «La disponibilidad de la formulación en suspensión de rufinamida puede ayudar a los pacientes jóvenes a seguir mejor el tratamiento, lo que permitirá obtener mejores resultados en el tratamiento de esta enfermedad grave y muy debilitante».

Quote approved



El SLG es una forma de epilepsia poco frecuente que representa un cinco por ciento de todos los casos y supone aproximadamente el 10 por ciento de los casos de epilepsia infantil.[1] La incidencia anual de la enfermedad afecta a aproximadamente 2,8 de cada 10.000 nacimientos en Europa.[1] La atención eficaz del SLG y el cumplimiento terapéutico son de vital importancia en los niños, ya que la enfermedad se caracteriza por numerosas crisis diarias, retraso mental y regresión.[2]

«La presentación del nuevo formato bebible de rufinamida en España permitirá abordar las necesidades de los niños y jóvenes con esta grave forma de epilepsia. Mejorar el cumplimiento terapéutico es un factor crucial para ayudar a reducir la frecuencia de las crisis, especialmente en personas jóvenes», afirma Fernando Álvarez, Epilepsy Business Unit Director  de Eisai Farmacéutica, S.A. «Eisai colabora estrechamente con los centros de epilepsia infantil españoles para garantizar que los pacientes tengan a su disposición el nuevo tratamiento lo antes posible. Esta forma de actuar está en consonancia con nuestro compromiso continuo con el área terapéutica de la epilepsia y nuestro objetivo de aumentar los beneficios que ofrecen nuestros  fármacos a los pacientes y sus familias a través de la misión de cuidado de la salud humana (hhc por sus siglas en inglés) de Eisai».

La preparación de la suspensión oral es equivalente en miligramos a los comprimidos de rufinamida comercializados actualmente. La rufinamida en suspensión oral recibió la opinión positiva del CHMP en septiembre de 2011 y obtuvo la autorización formal de la EMA en noviembre de 2011. El preparado fue aprobado por la FDA y se comercializó en los Estados Unidos en marzo de 2011 (la rufinamida se comercializa como BANZEL® en los Estados Unidos).  

El desarrollo de una formulación en suspensión oral bebible de rufinamida demuestra el compromiso de Eisai con el área terapéutica de la epilepsia y es un ejemplo de la contribución de la empresa a la satisfacción de las diversas necesidades de los pacientes y sus familias y el aumento de los beneficios que reciben, como muestra su misión de cuidado de la salud humana  (hhc por sus siglas en inglés).

Acerca de Inovelon® (rufinamida)

La rufinamida es un derivado de triazol que carece de relación estructural con los fármacos antiepilépticos (FAE) que se comercializan actualmente. Se cree que regula la actividad de los canales de sodio del cerebro que transmiten cargas eléctricas excesivas. El  fármaco se aprobó como terapia coadyuvante para el SLG en Europa (con el nombre comercial de Inovelon®) en 2007.[3] Inovelon® está disponible en forma de comprimidos recubiertos que contienen 100 mg, 200 mg y 400 mg de rufinamida.

La formulación de rufinamida en comprimidos recubiertos se comercializó por primera vez en Europa en mayo de 2007 y actualmente está disponible en 19 países europeos.

Acerca del síndrome de Lennox-Gastaut

El SLG es una forma debilitante de epilepsia de inicio infantil que aparece con mayor frecuencia entre las edades de dos a siete años. Se caracteriza por crisis frecuentes y de múltiples tipos y suele ir acompañada de retraso mental y problemas psicológicos y de comportamiento.[4]

Acerca de la epilepsia

La epilepsia es uno de los trastornos neurológicos más comunes del mundo, que afecta aproximadamente a 8 de cada 1.000 personas en Europa[5] y se estima que viven con epilepsia seis millones de personas en Europa[6]y 50 millones de personas en todo el mundo[7], de las cuales 10,5 millones son niños menores de 15 años.[8]

La epilepsia se caracteriza por la activación anormal de los impulsos de las células nerviosas del cerebro, que causa las crisis. En función del tipo de crisis, estas pueden limitarse a una parte del cuerpo o pueden generalizarse para afectar a todo el cuerpo.

Los pacientes también pueden experimentar sensaciones anormales y alteraciones del comportamiento o de la conciencia. La epilepsia es un trastorno con muchas posibles causas. Con frecuencia se desconoce la causa de la epilepsia. No obstante, cualquier hecho que altere el patrón normal de la actividad neuronal, desde enfermedades hasta daños cerebrales o tumores, puede producir crisis.[9]

Acerca de Eisai Europa en relación con la epilepsia

Eisai está comprometida con el desarrollo y el suministro de nuevos tratamientos beneficiosos para ayudar a mejorar las vidas de las personas con epilepsia. El desarrollo de FAE es una importante área estratégica para Eisai en Europa, Oriente Medio, África y Rusia (EMEA).

En Europa, Eisai comercializa actualmente tres medicamentos:

  • Zonegran® (zonisamida) como monoterapia y tratamiento coadyuvante en pacientes adultos con crisis de inicio parcial con generalización secundaria o sin ella. (Zonegran® está bajo licencia de Dainippon Sumitomo Pharma)
  • Zebinix® (acetato de eslicarbazepina) como tratamiento adyuvante en pacientes adultos con crisis de inicio parcial, con o sin generalización secundaria. En España, el representante local del laboratorio titular de la autorización de comercialización de Zebinix® en la Unión Europea es Bial Industrial Farmacéutica, S.A.
  • Inovelon® (rufinamida) para el tratamiento adyuvante en pacientes de 4 y más años de crisis asociadas con el síndrome de Lennox-Gastaut.
  • Fycompa® (perampanel) como tratamiento coadyuvante para las crisis de inicio parcial, con crisis secundarias generalizadas o sin ellas, en pacientes con epilepsia mayores de 12 años.

Acerca de Eisai

Eisai ha ampliado recientemente sus instalaciones comerciales, de investigación y producción en Hatfield, Reino Unido, que ahora respaldan el crecimiento del negocio de la empresa en EMEA.

Eisai concentra sus actividades de I+D en tres áreas fundamentales:

  • Área de Neurociencias, que incluye enfermedad de Alzheimer, dolor neuropático, epilepsia, dolor y pérdida de peso.
  • Área de Oncología: tratamientos contra el cáncer; regresión tumoral, supresión tumoral, anticuerpos, etc.
  • Vascular / respuesta inmunológica, incluyendo trombocitopenia, artritis reumatoide, psoriasis, enfermedad inflamatoria intestinal.

Con filiales en los Estados Unidos, Asia, Europa y Japón, Eisai tiene más de 11.000 empleados en todo el mundo. En Europa, Eisai tiene filiales comerciales en más de 20 países que incluyen el Reino Unido, Francia, Alemania, Italia, España, Suiza, Suecia, Irlanda, Austria, Dinamarca, Finlandia, Noruega, Portugal, Islandia, República Checa, Eslovaquia, Países Bajos, Bélgica, Luxemburgo, Oriente Medio y Rusia.

Si desea más información visite nuestro sitio web http://www.eisai.com

Bibliografía

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/ (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. 21-259.

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)


Fecha de preparación: Enero de 2013

Código de trabajo: Inovelon-UK2277

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
The cloud is now a fact of life but generating recurring revenues that are driven by solutions and services on a consumption model have been hard to implement, until now. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, will discuss how a top European telco has leveraged the innovative recurring revenue generating capability of the consumption cloud to enable a unique cloud monetization model to drive results.
As organizations shift toward IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection &E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 16th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships, will discuss how to cut costs, scale easily, and unleash insight with CommVault Simpana software, the only si...
Analytics is the foundation of smart data and now, with the ability to run Hadoop directly on smart storage systems like Cloudian HyperStore, enterprises will gain huge business advantages in terms of scalability, efficiency and cost savings as they move closer to realizing the potential of the Internet of Things. In his session at 16th Cloud Expo, Paul Turner, technology evangelist and CMO at Cloudian, Inc., will discuss the revolutionary notion that the storage world is transitioning from mere Big Data to smart data. He will argue that today’s hybrid cloud storage solutions, with commodity...
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, will focus on how to set up a cloud data governance program and s...
Roberto Medrano, Executive Vice President at SOA Software, had reached 30,000 page views on his home page - http://RobertoMedrano.SYS-CON.com/ - on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, and SOA World Magazine. He is a recognized executive in the information technology fields of SOA, internet security, governance, and compliance. He has extensive experience with both start-ups and large companies, having been involved at the beginning of four IT industries: EDA, Open Systems, Computer Security and now SOA.
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focused on understanding how industrial data can create intelligence for industrial operations. Imagine ...
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Every innovation or invention was originally a daydream. You like to imagine a “what-if” scenario. And with all the attention being paid to the so-called Internet of Things (IoT) you don’t have to stretch the imagination too much to see how this may impact commercial and homeowners insurance. We’re beyond the point of accepting this as a leap of faith. The groundwork is laid. Now it’s just a matter of time. We can thank the inventors of smart thermostats for developing a practical business application that everyone can relate to. Gone are the salad days of smart home apps, the early chalkb...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, representing a model of how to analyze rea...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, 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. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial Cloud.
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
Performance is the intersection of power, agility, control, and choice. If you value performance, and more specifically consistent performance, you need to look beyond simple virtualized compute. Many factors need to be considered to create a truly performant environment. In his General Session at 15th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, discussed how to take advantage of a multitude of compute options and platform features to make cloud the cornerstone of your online presence.
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along with a steady stream of well-publicized data breaches, only add to the uncertainty
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add scalable realtime functionality with minimal effort and cost.”
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...