Acceptability and palatability of an age-appropriate ethanol free oral liquid phenobarbital suspension in the paediatric population
Duration of Study in the UK
0 years, 6 months, 0 days
In the UK, medicines are carefully regulated to ensure that they are as safe as possible, work as intended and are made of suitable quality. Medicines are granted a product licence, now known as a marketing authorisation (MA), by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) when they are deemed to have met these strict safety and quality standards. As part of these regulations, manufacturers must include an assessment of how acceptable the medicine is for the intended user, before it is made available on the market, for wider use.
Historically, medicines have not always been designed with children in mind. Many medicines are only available in dosage forms, which are more suitable for use in adults. This leads to medicines having to be used in untested ways (so called “off-label” (OL) use), as they may not have been tested for use in certain age groups or they may need to be adapted / modified (e.g. a tablet is crushed and mixed with water) to allow administration to a child. Alternatively, unlicensed (UL) medicines may need to be sourced and purchased to fulfil this unmet clinical need.
One of the medicines identified which could benefit from an improved formulation for use in children is phenobarbital. A new, alcohol-free liquid formulation of phenobarbital has been developed by Proveca Ltd which is specifically designed for use in children. It can be used to treat all forms of epilepsy, except absence seizures. The aim of the study is to investigate, within a small group of patients who are already prescribed and taking oral phenobarbital, how they react to the new formulation. How acceptable is it to them? Do they like it? Do the results suggest that the product would be acceptable to a wider paediatric population?
East of England - Cambridge South Research Ethics Committee
Date of REC Opinion
13 Oct 2022
Further Information Favourable Opinion