Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on neurodevelopmental disorders, is pleased to announce that the first patients are being treated in EMMA, the planned follow-on study to the Company’s fully recruited SOFIA trial of fluoxetine in autistic disorder (NPL-2008).
Results from the Phase III SOFIA trial are on track to be announced in Q1 2009 and will form a key part of the Company’s New Drug Application (NDA), which is already underway through the Rolling NDA process following the submission in September 2008 of the Chemistry, Manufacturing and Controls (CMC) section.
Children and adolescents participating in the placebo-controlled SOFIA trial will have the opportunity to join the 18-month follow-on study, in which all patients will receive the Zydis® formulation of fluoxetine used in the SOFIA trial. The results of the study, which are expected to be available in H2 2010, are not intended to form part of the NPL-2008 NDA submission.
EMMA, an abbreviation for the Extended Management and Measurement of Autistic Disorder, represents the first sponsor-led study to assess the developmental impact of fluoxetine on children and adolescents over an extended period.
In the study, patients’ development will be assessed through the use of standardised IQ tests, appropriate to individual patients’ age and functional ability. This focus on IQ complements the SOFIA trial, which is measuring reduction in repetitive behaviours.
In common with SOFIA, the EMMA study is being carried out in collaboration with Autism Speaks, the US patient organization whose Clinical Trials Network co-ordinates research in specialist autism centres throughout the US.
Robert Mansfield, Neuropharm’s CEO, commented: “I am delighted that the first patients are now being treated in the EMMA follow-on study. This planned study provides an opportunity for patients on placebo in the SOFIA trial to benefit from the active ingredient. Its focus on measuring patients’ intellectual development is expected to provide extremely valuable data about the potential benefits of fluoxetine over an extended period.”
Neuropharm is a speciality pharmaceutical company focused on improving patient lives by delivering medicines for high unmet needs in the treatment and management of neurodevelopmental disorders. Please visit www.neuropharm.co.uk for further information.
NPL-2008 is currently in Phase III development for the treatment of repetitive behaviours in Autistic Disorder. Formulated especially for autistic children, the low dose, fast melt tablets have been designed specifically to make precision titration and everyday administration easier for parents.
Neuropharm’s Phase III study of NPL-2008 in SOFIA is currently ongoing at 16 sites in the US that comprise the Autism Speaks Clinical Trials Network of expert investigators. Autism Speaks is the world’s largest autism advocacy organisation. The results from this randomised, double-blind trial in more than 120 children and adolescents with Autism Disorder will form part of the Rolling NDA submission.
The NPL-2008 programme received Orphan Drug Designation from FDA in 1999, giving the product the potential for seven years of market exclusivity on receipt of regulatory approval. This programme received Fast Track Status from FDA in April 2008. Submission of a Rolling NDA and Priority Review are among a range of measures that may be granted within Fast Track Status. Priority Review is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced.