Post-authorisation safety study (PASS) completed for Glycopyrronium Bromide
The DSRU conducted a PASS in the UK on Glycopyrronium Bromide 1mg/5ml oral solution, a medicine which is prescribed to treat severe drooling in children aged three years and older with chronic neurological conditions. The study started in November 2021, and the final report was produced in November 2025. This final report is now being submitted to the MHRA. The study lead, Dr Sandeep Dhanda, tells us more about the study below.
What was the aim of the study?
The study aimed to monitor the use and safety of Glycopyrronium Bromide 1mg/5ml oral solution in patients aged under 18 years in the UK.
The study also evaluated whether the additional risk minimisation measures (aRMMs) for the medicine, which included a healthcare professional (HCP) checklist and a reminder card for caregivers, were effective.
What was the study design:
Paediatric HCPs within the UK were recruited via the National Institute for Health Research (NIHR). Any patient aged under 18 years who was started on Glycopyrronium Bromide 1mg/5ml oral solution as part of their routine clinical care was assessed for eligibility to take part in the study. Consent was obtained for each patient.
The DSRU then contacted the paediatric HCPs at 3, 6, 9 and 12 months to collect information from the patient’s secondary care medical records. Patients or their parent/guardian were also invited to complete questionnaires at 6 and 12 months following their initial prescription (optional). The DSRU also contacted the patient’s GP at 12 months to collect information from the patient’s primary care medical records.
The study collected information on use, adverse events (i.e., any event experienced by the patient after starting Glycopyrronium Bromide, but not necessarily considered to be caused by the medicine), and whether or not the HCP checklist and/or reminder card has been received.
What are the findings of the study?
14 sites (i.e., paediatric teams) participated in the study and recruited 17 eligible patients despite using a range of different approaches to encourage site and patient recruitment. Off-label use (i.e. in children under 3 years of age or relating to drooling severity) was reported in 6 patients (35%). Approximately 75% of patients had at least one of the pre-specified safety concerns listed in the HCP checklist; constipation was most frequently reported (35%) followed by pneumonia (18%). Whilst the adverse events reported were largely consistent with those included in the patient information leaflet (PIL), some adverse events were considered to be serious. For five of the 17 patients (29%), the HCP received the checklist which was part of the aRMMs. The reminder card was received for four patients (24%).
Summary of the study
This study used a combination of information collected from specialist secondary care teams, patients or their parents/guardians, and the patients’ GPs. Although the study size was small, the study shows that the drug is used off-label and that the adverse event profile is consistent with the information in the PIL. With regards to the aRMMs, it was apparent that there were difficulties with ensuring both the HCP and the patient received the necessary materials (HCP checklist and reminder card). The study has also helped to highlight some other important challenges, particularly regarding patient recruitment in this therapeutic area. We would like to thank all families and HCPs who took part in the study.