Martindale Pharma® News

Pivotal study highlights new buprenorphine wafers could help thousands battling opioid addiction

Wooburn Green, Buckinghamshire, 5th May 2017 – Martindale Pharma has today announced results from a Phase II randomised study published in European Addiction Research on Espranor – the rapidly dissolving oral lyophilisate formulation of buprenorphine. Data on this unique opioid substitution therapy (OST) show that, when compared with current hard sublingual (under the tongue) tablets, the novel formulation dissolved quickly with no increased safety concerns and no demonstrable difference in efficacy1. Espranor represents the first major advance in OST for 10 years2. With tens of thousands of people across the UK suitable for treatment with buprenorphine, data such as these may support wider prescribing, improved care and reduced burden on healthcare providers who supervise OST.3,4

“Buprenorphine plays a vital role in opioid substitution therapy for many patients. However, it is recognised that a significant barrier has been the time-consuming and often stigmatising process of supervising its administration,” said Dr Baillie, Group Medical Director of Martindale Pharma. “These data demonstrate that using this rapidly-dissolving formulation of buprenorphine may offer practical benefits without compromising safety or efficacy.”

The study assessed the safety of the new buprenorphine oral lyophilisate wafer versus standard sublingual buprenorphine tablets, (Subutex). Patients (n=36) were opioid-dependent, commencing buprenorphine maintenance and were treated in a specialised clinical trials or addictions treatment facility. Results showed that 96.3% of Espranor administrations achieved partial disintegration on the tongue within 15 seconds, meaning at this time point the wafer could no longer be removed from the mouth intact. Overall the median time to complete disintegration of the Espranor wafer was two minutes compared with 10 minutes for standard sublingual buprenorphine tablets (p< 0.0001). There were no significant between-group differences in opiate-withdrawal phenomena, craving or adequacy of “hold,” or respiratory function. No serious adverse events (AEs) were observed. Although more mild AEs and treatment-emergent AEs were observed with the wafer formulation, all events were transient and self-limiting. Pharmacokinetic analysis found greater bioavailability of buprenorphine but not nor-buprenorphine with Espranor.1

“It is vital that we find better ways of supporting people across the UK battling opioid addiction,” said Annemarie Ward, CEO of Faces and Voices of Recovery. “These results are promising as they indicate that, by just using a simpler form of buprenorphine, we may increase its use and reduce some of the problems seen with conventional pills. Having another choice of treatment available is always a cause for celebration. The challenge now will be to explore how we help those on the front lines of OST understand how and when it should be used.”

Estimates suggest that there are 350,000 heroin or opiate users in the UK and Ireland with approximately 230,000 in treatment, mostly on OST, for example methadone or buprenorphine.3 Current treatments still fail many patients, with approximately 50% of patients dropping out of both buprenorphine and methadone maintenance treatment within six months.1 While sublingual buprenorphine is used in the UK, it has distinct limitations, taking between five to ten minutes to dissolve and often requiring close supervision in some settings.2,5,6 This has been shown to place burden on healthcare providers and to be associated with negative stigma for some patients.5 Rapidly-dissolving formulations of buprenorphine may minimise supervision times and have the potential to reduce the opportunity for the diversion of medicines for misuse.4

Notes to editors:

About Espranor® (buprenorphine oral lyphilisate)7,8
Buprenorphine oral lyphilisate is a novel, freeze-dried wafer formulation of buprenorphine which disintegrates rapidly when placed on the tongue. It is indicated for substitution treatment for opioid drug dependence, within a framework of medical, social, and psychological treatment. Treatment with Espranor is intended for use in adults and adolescents aged 15 years or over who have agreed to be treated for addiction.

Espranor is available on prescription across England and Wales and is currently being reviewed by the Scottish Medicines Consortium for use in Scotland.

About Martindale Pharma
Martindale Pharma is a leading UK-based specialty pharmaceutical company providing essential medicines to over 50 countries around the world. Martindale Pharma’s strategy is to build leading positions in defined business segments where there is a high unmet medical need and a demand for improved product presentations. Martindale Pharma focuses on Opioid Addiction, Emergency Care and Hospital-initiated Medicines.
With a strong UK presence and expertise in marketing hospital and specialty medicines, Martindale Pharma is recognised as a strategic partner to the NHS and other healthcare providers, supplying over 100 licensed products, and has a track record of successful new specialty product launches.
The business also includes a rapidly growing international organisation currently centred on three geographical regions: Saudi Arabia and the Gulf Co-Operation Council territory, Australia and South East Asia and Northern Europe.
www.martindalepharma.co.uk

About Ethypharm
Ethypharm is an independent pharmaceutical company with global reach. It is dedicated to developing innovative drugs to treat pain and addiction, two major therapeutic areas with large unmet medical needs. Ethypharm also develops complex generics that contribute towards optimization of healthcare costs. Ethypharm employs 950 people, mostly in France where its innovation centre is based as well as two high quality manufacturing sites. Ethypharm drugs are currently marketed in 30 countries around the world.
Since July 2016, Ethypharm is held by funds advised by PAI Partners, a leading European private equity firm headquartered in France. PAI Partners manages over €8 billion of dedicated buyout funds and provides financial and strategic support to Ethypharm.
www.ethypharm.com

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1 Strang 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.
2 Suboxone® 8mg/2mg Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/26225. Last accessed March 2017.
3 Opiate Addiction in the UK & its consequences. The Abstinence Centre. Available at: http://www.theabstinencecentre.com/opiate-addiction-in-the-uk-its-consequences. Last accessed March 2017.
4 Reed K, et al. Buprenorphine in a novel lyophilised instant-melt formulation: testing safety and pharmacokinetics. Presented at SSA PhD Symposium 2015, Bath, UK.
5 Drug misuse and dependence. UK guidelines on clinical management, 2007. Available at:
http://www.nta.nhs.uk/uploads/clinical_guidelines_2007.pdf. Last accessed March 2017.
6 Subutex® 2mg Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/26461. Last accessed March 2017.
7 Espranor® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/32760 2mg Last accessed March 2017.
8 Espranor® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/32761 8mg. Last accessed March 2017.