The TAIN project
TAIN stands for
Treatment of Adrenal
Insufficiency in Neonates and
Infants and was supported by the European Commission through its
7th Framework Programme. TAIN started on the 1st December
2011.
The aim of TAIN was to develop a new formulation of
Hydrocortisone -
Infacort® - that can be used from birth and
specifically in the age range of 0-2 years (neonates &
infants). Hydrocortisone is an essential glucocorticoid hormone
used as a replacement therapy for the treatment of the rare disease
adrenal insufficiency - where the body cannot produce sufficient
cortisol. The problem of effective Hydrocortisone replacement is
especially acute in this young patient range, for whom no licensed
therapy exists.
TAIN involved European leaders in drug development, neonatology
and paediatric pharmacology. A Paediatric Investigation Plan (PIP)
was developed that enabled clinical trials to be carried out to
provide sufficient evidence of safety and efficacy for
Infacort® to allow submission of a Paediatric Use
Medicines Authorisation (PUMA) to the European Medicines Agency
(EMA).
TAIN also aimed to raise awareness of paediatric adrenal
insufficiency by working closely with parents, patient groups and
clinicians. This allowed the work being conducted through TAIN to
benefit the widest possible number of children, their families and
health professionals.
The TAIN Project was successfully completed on the
30th November 2016 with the
submission of a Paediatric Use Market Authorisation (PUMA)
application to the European Medicines Agency.