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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

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