PARÍS, 4 de junio de 2021 /PRNewswire/- La Agencia Europea del Medicamento acaba de emitir un dictamen favorable a la solicitud de autorización de comercialización de OZAWADE™ (pitolisant), indicado para el tratamiento de la somnolencia diurna excesiva (SDE) relacionada con la apnea obstructiva del sueño en adultos.
OZAWADE™ está indicado para mejorar la vigilia y reducir la SDE en pacientes adultos con síndrome de apnea obstructiva del sueño (SAOS) cuya SDE no ha sido tratada satisfactoriamente con un tratamiento primario del SAOS, como la presión positiva continua (PPC). También está indicado en personas que no toleran la PPC.
El pitolisant es un antagonista/agonista inverso del receptor de la histamina H3 descubierto por Jean-Charles Schwartz, sus colaboradores en el Inserm y la empresa Bioprojet de París, con la ayuda de dos químicos europeos (Walter Schunack, de la Universidad de Berlín, y Robin Ganellin, del University College de Londres). Al bloquear los autorreceptores de la histamina, pitolisant aumenta la actividad de las neuronas histaminérgicas cerebrales, un importante sistema de excitación con proyecciones extendidas a todo el cerebro. El pitolisant también aumenta la liberación de acetilcolina, noradrenalina y dopamina en el cerebro. Este fármaco ya estaba indicado en Europa y Estados Unidos para el tratamiento de la SDE y cataplejía en pacientes con narcolepsia.
La eficacia y la seguridad de pitolisant en el tratamiento de la SDE en pacientes con SAOS se han estudiado en dos ensayos clínicos de fase III multicéntricos, aleatorizados, doble ciego, frente a placebo: HAROSA I y HAROSA II. En el primero, los pacientes fueron tratados con PPC, pero aún se quejaban de SDE. En el segundo, los pacientes no toleraban el tratamiento con PPC y sufrían SDE.
Ambos estudios mostraron principalmente una mejora significativa en la puntuación de la escala de somnolencia de Epworth (ESS) en pacientes tratados con pitolisant. No se observaron incidentes cardiovasculares notables ni cambios significativos en la presión arterial y la frecuencia cardíaca.
Según diversos estudios epidemiológicos, mil millones de personas en el mundo presentan SAOS, con importantes consecuencias en la salud global y en particular en el funcionamiento de diferentes órganos[1]. La somnolencia diurna excesiva suele ser el síntoma más mencionado por los pacientes. Se asocia con frecuencia a cansancio, problemas de alerta y concentración, irritabilidad y síntomas de depresión. Las dificultades que experimentan los pacientes para afrontar todas sus tareas cotidianas repercuten en su calidad de vida y en la de sus seres queridos, pero también en la comunidad (costes sanitarios, disminución de la productividad, aumento del riesgo de accidentes)[2].
Acerca de Bioprojet
El laboratorio Bioprojet nació en 1982 gracias a la iniciativa de dos investigadores, Jeanne-Marie Lecomte y Jean-Charles Schwartz, cuyo propósito era acercar la investigación académica al desarrollo farmacéutico industrial, una práctica poco extendida en ese momento.
Bioprojet persigue un objetivo: apoyarse en trabajos originales de investigación fundamental para concebir y desarrollar medicamentos que, como el pitolisant, serían los primeros de nuevas clases terapéuticas.
Bioprojet está implantado en siete países europeos y su centro de investigación concibe y estudia mil moléculas nuevas cada año.
www.bioprojet.com
Este comunicado de prensa contiene información sobre el resumen de las características del producto (RCP) de OZAWADE™. Esta información está destinada a profesionales sanitarios. No debe considerarse como reclamo o promoción de productos si dichas actividades están prohibidas. Su difusión es responsabilidad de los periodistas.
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