Dr Simon Bryson
Chief Executive Officer and Co-Founder, Proveca
Dr Helen Shaw
Medical Director and Co-Founder, Proveca
A lack of medicines designed specifically for children is leaving serious gaps in children’s healthcare provision.
Many medications taken by children continue to be adapted from adult drugs, leaving young people potentially at risk from uncertain dose measurements.
While major pharmaceutical companies cater for child patients in areas such as diabetes or asthma, the less common conditions of heart failure, epilepsy, cerebral palsy and other rare diseases are often overlooked, according to Dr Simon Bryson, Chief Executive Officer of pharmaceutical company Proveca.
At present, 50-90% of medicines prescribed for children are not licensed for use in young people, so there is clear need for customised design and innovation in this “poorly-served” area of children’s healthcare.
Adverse effects
Using adult medicines for children carries risks; there may be limited evidence that a reduced adult dose is safe and effective. Children may also resist taking adult medication because of the taste or dose format such as large tablet size.
Excipients (additives to medicines for taste and other characteristics) are also an area of real concern, as certain additives can have an adverse effect on a child and need to be evaluated fully during the drug licensing process.
Proveca is working hard to address these gaps by taking medicines previously developed for adults and redesigning them for the paediatric population, through extensive clinical trials and a European licensing process specifically for children’s medicines.
50-90% of medicines prescribed for children are not licensed for use in young people, so there is clear need for customised design and innovation in this “poorly-served” area of children’s healthcare.
Effective drugs that are well accepted
The company creates medicines that have the correct package of information to demonstrate safety and efficacy in children, as well as in doses and formats more acceptable to children in terms of taste, smell, touch, colour and sensation on the palate. They do this by designing innovative medicine formats, such as mini tablets that will dissolve rapidly on the tongue, or syrups with more children friendly flavours.
Dr Bryson says: “Presentation of a medicine in an ideal format is really important. If it is not acceptable to a child, then adherence to that medication is going to be inhibited.”
“While sometimes adapting an adult medicine may be the only available option, it can lead to a child not receiving the appropriate dose, with the risks of over, or under, dosing. Both doctors and pharmacists tell us that they are keen to have a children specific, licenced medicine available for every child” he says.
Focussing on children’s medicines
Proveca’s Medical Director, Dr Helen Shaw, says “adaptation of adult medicines for children is widespread and accepted as the only option for many childhood diseases.” She acknowledged that “until there are more medicines specifically designed and licensed for children, doctors have little alternative but to use adult medicines to enable them to treat a child.”
“What we are developing,” continues Dr Shaw, “is a child specific, patient-centred medicine, that is easy to deliver at the correct dose in a simple and child friendly way.”
Clinical trials disrupted
Over the last few months, the coronavirus pandemic has disrupted ongoing and new clinical trials, slowing development and licensing of new drugs, with the emphasis and funding concentrating on research into COVID-19.
The pandemic has also hampered clinical programmes and reduced face-to-face interaction with patients and clinicians, but Dr Shaw does draw some positives from the situation.
Educational programmes delivered virtually are reaching wider audiences and events over the last year have shown how quickly clinical trials can be set up and medicines developed and licensed if people work together in new and collaborative ways.
“There are some really important lessons to take out of that as a way of working that we should not lose,” she says.
Post-Brexit, Proveca has worked to maintain its Europe-wide reach in terms of developing, distributing and licensing products, and clinical trial collaboration, by establishing a hub in Dublin to deliver its European programme of work from Ireland. It is still retaining a footprint in the UK in Manchester.
See more at www.proveca.com
RoI-PRO-2021-005
Created March 2021
