Wooburn Green, Buckinghamshire, 12th June 2017 –

Martindale Pharma has today announced that the Scottish Medicines Consortium (SMC) has recommended Espranor (buprenorphine oral lyophilisate), a new treatment for opioid drug addiction, for restricted use within NHS Scotland.

This first fast-dissolving treatment has been approved as a substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment for patients aged 15 years and over who have agreed to be treated for opioid drug addiction and for whom methadone is not suitable.1 Espranor represents the first major advance available in opioid substitution therapy (OST) for 10 years.2 “For many of us the current drug problem needs new solutions, one of which is a bigger range of opiates and modalities of delivery than is currently available for medical assisted treatment. Espranor is a significant advance in extending the management of opiate drug problems in its ability to dramatically reduce supervision time allowing, or eliminating, some of the limiting factors in daily management in communities and custody situations,” said Roy Robertson, a GP in Edinburgh, Professor of Addiction Medicine at Edinburgh University and Chair of the Scottish Government group on Harm Reduction. “Espranor has the potential to extend treatment to a large group and to draw in those currently not in supportive treatment. This could be a serious advantage in our attempts to limit the damage and prevent the alarming rate of drug related deaths.”  The majority of people in Scotland accessing opioid substitution therapy are treated with methadone and just over 15% receive buprenorphine or buprenorphine and naloxone.3 Licenced buprenorphine is currently in the form of a compressed sublingual tablet which usually takes between 5 and 10 minutes to dissolve and carries the risk of diversion and misuse.4,5 As a result of this patients may experience close supervision throughout their treatment and this lengthy supervised self-administration procedures are often regarded as humiliating and such stigma presents a barrier to buprenorphine uptake.4 Current treatments still fail many patients, with approximately 50% of patients dropping out of both buprenorphine and methadone maintenance treatment within six months.6

“Combating opioid addiction is a huge issue in Scotland and today’s announcement is great news for patients who want to be treated for their addiction but are failing on their current treatment,” said Annemarie Ward, CEO of Faces and Voices of Recovery. “Having another choice of treatment available is always a cause for celebration and now being able to offer a simpler form of buprenorphine, we may increase its use and reduce some of the problems seen with conventional pills.” Recently published data on Espranor show that, when compared with current hard sublingual (under the tongue) tablets, the novel formulation dissolved quickly with no increased respiratory safety risk or concerns and no significant difference in efficacy.6

1 Buprenorphine 2mg, 8mg oral lyophilisate (Espranor®) Detailed Advice Document. Scottish Medicines Consortium. May 2017.

2 Suboxone® 8mg/2mg Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/26225. Last accessed June 2017.

 

3 Scotland Summary Data. All Prescriptions. Prescribing for Opioid Dependence in Scotland – BNF Section 04.10.03. Financial Years 2005/06 to 2014/15.
4 Drug misuse and dependence. UK guidelines on clinical management, 2007. Available at:

http://www.nta.nhs.uk/uploads/clinical_guidelines_2007.pdf. Last accessed June 2017
5 Subutex® 2mg Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/26461. Last accessed June 2017.

 

6Strang et al. Randomised Comparison of a Novel Buprenorphine Oral Lyophilisate versus Existing Buprenorphine Sublingual Tablets in Opioid-Dependent Patients: A First-in-Patient Phase II Randomised Open Label Safety Study. Eur Addict Res 2017;23:61–70.
7 Drug-related deaths in Scotland in 2015. National Record of Statistics. August 2016.
8 Estimating the National and Local Prevalence of Problem Drug Use in Scotland 2012/13. Information Services Division. NHS Scotland. May 2016.

 

9 Overview of Initial Assessments for Specialist Drug Treatment 2015/16. Scottish Drug Misuse Database. April 2017.
10 Espranor® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/32760 2mg Last accessed June 2017.
11 Espranor® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/32761 8mg. Last accessed June 2017.

 

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