El ensayo alcanzó su índice principal de eficacia en la suma de la Escala Unificada de Calificación (UPDRS) de la enfermedad de Parkinson las partes II y III de la puntuación al final del estudio. La UPDRS Parte II mide las actividades de la vida diaria y la UPDRS Parte III medidas de los síntomas motores de la EP. Las tres dosis de IPX066 mostraron una mejoría significativa en comparación con el placebo (p <0,0001 para todos los tratamientos). El valor promedio de las partes II y la puntuación UPDRS III en el tratamiento IPX066 mejorado 13,2 unidades (36%) en comparación con una mejora de 0,6 unidades (2%) con el tratamiento con placebo, lo que indica una mejora mas importante en la gravedad de los síntomas EP de los pacientes con EP en etapas iniciales, como resultado IPX066 de tratamiento.
"Estamos encantados de informar de estos resultados positivos del ensayo APEX-PD que demuestran la eficacia en la enfermedad de Parkinson en etapa temprana a través de una serie de medidas objetivas y subjetivas para cada una de las dosis probadas", declaró el doctor Suneel Gupta, Director Científico de Productos Farmacéuticos Impax . "Estamos trabajando diligentemente para completar el programa de ensayos clínicos en la fecha prevista y el objetivo presentar una solicitud de nuevo fármaco a finales de 2011."
APEX-PD Trial Shows Efficacy, Safety of IPX066 in Early Parkinson's
Impax Laboratories Inc has announced positive top-line results of a phase 3 trial of IPX066, an investigational extended-release formulation of carbidopa-levodopa.
The APEX-PD trial met its primary efficacy endpoint of change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III scores, reflecting improvements in activities of daily living and motor symptoms of Parkinson's disease (PD).
APEX-PD is the first of 2 pivotal phase 3 studies to support a New Drug Application for IPX066 in PD, the company notes in a statement November 18. Investigators plan to report full results at a future medical meeting.
Reducing Off Time
IPX066 is an extended-release carbidopa-levodopa formulation aimed at producing a rapid and sustained concentration of levodopa to improve symptom management and potentially reduce off time in PD patients. The extended-release formulation could also reduce dosing frequency, which would be more convenient for patients, the statement points out.
APEX-PD was a randomized, double-blind, placebo-controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 with placebo in 381 patients with early PD. Patients took 1 of 3 oral doses or matching placebo 3 times daily for 30 weeks.
"The study was conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) and is part of the IPX066 clinical development plan agreed with the FDA and the European Medicines Agency," the statement notes.
The company reports significant improvement on the primary efficacy endpoint compared with placebo for all 3 doses of IPX066 (P < .0001 for all comparisons). The mean sum of the Parts II and III UPDRS score on IPX066 treatment improved 13.2 units (36%) vs 0.6 units (2%) with placebo.
Treatment was also associated with mean improvements of 72% in both Clinician Global Impression of change (CGI) and Patient Global Impression of change (PGI) compared with 27% and 34% for placebo in CGI and PGI, respectively (P < .0001 for both measures at all 3 dose levels).
Treatment also resulted in an improvement over placebo in quality of life as measured by the Parkinson's Disease Questionnaire at week 30 (P < .02).
The most commonly reported adverse events in the IPX066 treatment arms included nausea, headache, and dizziness, which are consistent with carbidopa-levodopa products, the statement said. Adverse events occurred in similar proportions of IPX066- and placebo-treated subjects, 69% compared with 73%, respectively. No unexpected drug-related serious adverse events were observed in IPX066-treated subjects, the statement adds.
ADVANCE-PD, a phase 3 study of IPX066 vs immediate-release carbidopa-levodopa in advanced PD patients with motor fluctuations, is ongoing. That trial has completed enrollment, and results are expected in the second quarter of 2011, the company notes.
"We are working diligently to complete the clinical trial program on schedule and target a New Drug Application (NDA) filing by the end of 2011," said Dr. Suneel Gupta, chief scientific officer of Impax Pharmaceuticals.
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