DIAPASS: Ayendi Observational Study
Research type
Research Study
Full title
A Multicentre, Non-interventional, Prospective, Observational Drug Utilisation Study of Ayendi Nasal Spray Prescribed as Treatment in Emergency Departments in the United Kingdom (UK)
IRAS ID
150874
Contact name
Deborah Roberts
Contact email
Sponsor organisation
Wockhardt UK Ltd
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ayendi Nasal Spray has already been granted a Marketing Authorisation (MA)in the UK. However, the MHRA, on granting the licence, have required the manufacturer and Marketing Authorisation Holder (MAH), Wockhardt, conduct a Post Authorisation Safety Study to evaluate the practical use of Ayendi Nasal Spray in EDs.\nThe active ingredient in Ayendi Nasal Spray is diamorphine, which has been used to treat severe, acute pain in children for many years. With Ayendi Nasal Spray, the diamorphine (in a saline solution) is sprayed into the child’s nose instead of being administered by injection or nasal drops. Ayendi Nasal Spray has been specially designed to deliver an accurate dose of the pain relief medicine. \nPrevious studies have shown that Ayendi Nasal Spray scores significantly better than morphine injection when patients, legal guardians and hospital staff assess the pain reduction the drug provides. Almost none of the drug is lost down the back of the throat (a problem encountered when the drug is administered by nasal drops). \nThe benefits of Ayendi Nasal Spray have been found to outweigh any risk however, this additional, observational study has been requested to provide more information about errors in prescribing and dosing using Ayendi Nasal Spray and information on Ayendi Nasal Spray when given with other medicines, particularly other opiate-based pain medicines. The study will also look at how effective the currently advised instructions for use provided to the prescriber are. \nThis study requires no intervention in the patient’s treatment as the patients recruited into and consented for the study will have already been treated with Ayendi Nasal Spray as part of their routine care\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0332
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion