Comment: The sponsor's rational for the armodafinil clinical development program is acceptable. Contents of the clinical dossier Scope of the clinical dossier The submission contained the following clinical information: 11 Phase I clinical pharmacology studies, including pharmacokinetic data with or without pharmacodynamic data (9 in healthy subjects, 1 in patients with schizophrenia, and 1 in patients with OSAHS). 1 population pharmacokinetic report, 1 pharmacokinetic/pharmacodynamic modelling and simulation report. 4 pivotal III, double-blind, placebo controlled studies (2 in patients with OSAHS, 1 in patients with narcolepsy, 1 in patients with SWSD). 2 Phase III, open-label studies each including patients with narcolepsy, OSAHS or SWSD. 2 Phase IIIb studies (1 double-blind, placebo-controlled study in patients with SWSD, 1 open-label study in patients with OSAHS or narcolepsy). 4 in vitro bioanalytical reports; 2 human biomaterial reports. Literature references. Paediatric data The sponsor has not applied to the European for a waiver relating to the submission of paediatric studies for the treatment of OSAHS, narcolepsy or SWSD. The FDA (USA) has granted a waiver for paediatric studies in patients from birth to 17 years of age in OSAHS "on the basis that studies are highly impractical because the number of patients is so small or non-existent", and in SWSD "on the basis that very few, if any, paediatric patients experience excessive sleepiness associated with" this condition. The FDA granted a partial waiver for the paediatric study requirement for patients aged less than 6 years with narcolepsy "on the basis that studies are highly impractical because the number of patients is so small or non-existent". However, the FDA deferred the paediatric study requirement for patients aged 6 to 17 years with narcolepsy until November 2017 "on the basis that the other paediatric groups are subject to a waiver request". Good clinical practice The sponsor states that the clinical studies were undertaken in compliance with the principles of Good Clinical Practice.
Comment: The sponsor's rational for the armodafinil clinical development program is acceptable. Contents of the clinical dossier Scope of the clinical dossier The submission contained the following clinical information: 11 Phase I clinical pharmacology studies, including pharmacokinetic data with or without pharmacodynamic data (9 in healthy subjects, 1 in patients with schizophrenia, and 1 in patients with OSAHS). 1 population pharmacokinetic report, 1 pharmacokinetic/pharmacodynamic modelling and simulation report. 4 pivotal III, double-blind, placebo controlled studies (2 in patients with OSAHS, 1 in patients with narcolepsy, 1 in patients with SWSD). 2 Phase III, open-label studies each including patients with narcolepsy, OSAHS or SWSD. 2 Phase IIIb studies (1 double-blind, placebo-controlled study in patients with SWSD, 1 open-label study in patients with OSAHS or narcolepsy). 4 in vitro bioanalytical reports; 2 human biomaterial reports. Literature references. Paediatric data The sponsor has not applied to the European for a waiver relating to the submission of paediatric studies for the treatment of OSAHS, narcolepsy or SWSD. The FDA (USA) has granted a waiver for paediatric studies in patients from birth to 17 years of age in OSAHS "on the basis that studies are highly impractical because the number of patients is so small or non-existent", and in SWSD "on the basis that very few, if any, paediatric patients experience excessive sleepiness associated with" this condition. The FDA granted a partial waiver for the paediatric study requirement for patients aged less than 6 years with narcolepsy "on the basis that studies are highly impractical because the number of patients is so small or non-existent". However, the FDA deferred the paediatric study requirement for patients aged 6 to 17 years with narcolepsy until November 2017 "on the basis that the other paediatric groups are subject to a waiver request". Good clinical practice The sponsor states that the clinical studies were undertaken in compliance with the principles of Good Clinical Practice.
auspar-armodafinil-160526-cer_0.docx