Clinical Data Sevodyne2020-02-07T10:45:36+00:00

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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

sevodynemultiplev2

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 3.0 August 2019

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DEPENDABLE SUPPLY CHAIN.

For further information please call: 01730 231148,
email: info@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_6_07.02.2020

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