Clinical Data
Sevodyne meets all the relevant regulatory requirements of a bioequivalent medicine (reference product: Norspan® [(buprenorphine patches) Mundipharma Gmbh, Germany]/BuTrans® [(buprenorphine patches) Napp Pharmaceuticals Ltd, UK]).1 Two bioequivalence studies were performed, one single-dose study and a multi-dose study, and an adhesion study was also performed.1
Single-dose study comparing Sevodyne 20 microgram/hr transdermal patch and Norspan 20 microgram/hr transdermal patch
Multiple-dose study comparing Sevodyne 20 microgram/hr transdermal patch
and Norspan 20 microgram/hr transdermal patch
The adhesion study showed that both Sevodyne and Norspan had overall mean adherence (over 168 hours of patch wear) higher than 90%.1
References: 1) Data on file, 1010067149 v 5.0 November 2021
TRUSTED BRANDS.
DEPENDABLE SUPPLY CHAIN.
For further information please call: 01730 231148,
email: customerservices@aspirepharma.co.uk or visit www.aspirepharma.co.uk
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148
For more information about Sevodyne, please see the abbreviated prescribing information.
Revision reference – Sevodyne_11_29.11.2021
