Prenoxad Injection Approved in Five European Countries Opening Way for Pan-European Availability of a Take-home Naloxone Product

11 May, 2016, 04:00 ET from Martindale Pharma

WOOBURN GREEN, England, May 11, 2016 /PRNewswire/ --

- Significant Opportunity to Reduce Opioid Overdose Deaths  

- Prenoxad Injection to be Filed for Regulatory Approval in France in Summer 2016  


Martindale Pharma, UK-based international specialty pharmaceutical company, today announced the regulatory approval of Prenoxad Injection in Sweden, Denmark, Ireland, Finland and Estonia following the successful completion of a decentralised procedure (DCP).

Developed by Martindale Pharma, Prenoxad Injection is the world's first take-home naloxone product, designed for use by non-healthcare professionals to treat opioid overdoses in a community setting. Prenoxad Injection is available in the UK and over 85,000 units or kits have been supplied to people who are at risk of opioid related overdose or to their nominated representative.

Commenting on the approval Michael Harris, CEO of Martindale Pharma, said: "As a company committed to improving outcomes in tackling opioid addiction, we are delighted to see our leading take-home naloxone product take a major step forward towards reducing opioid overdose deaths in five new European countries. Prenoxad Injection has already been shown to reduce opioid overdose deaths when offered as part of a harm reduction programme in the UK, and this important regulatory step will help that goal be achieved in many more countries."

In addition, Martindale Pharma announced the out-licensing of exclusive commercial rights to Prenoxad Injection for France to Ethypharm, a pain and addiction focused specialty pharmaceutical company. Financial terms were not disclosed.

Michael Harris added: "We are very pleased to have found an experienced partner to take Prenoxad Injection through the regulatory and launch processes in France, which we see as a key market for our opioid addiction business."

According to the European Monitoring Centre for Drugs and Drug Addiction approximately 1.3 million people in Europe suffer from opioid addiction. Evidence shows that accidental overdose is a leading cause of death in drug users, with around 6,500 men and women dying of an overdose each year across Europe.

The availability of naloxone to people at risk of overdose and their friends and families as a life saving measure has been endorsed by a wide range of regulatory and policy bodies in this field. Systematic reviews have shown that take-home naloxone programmes prevent overdose fatalities.

Although take-home naloxone is supported by the World Health Organisation, many people across Europe face significant barriers to accessing this life saving drug.

Mags Maher, Coordinator for the European Network of People Who Use Drugs (EuroNPUD) said: "We welcome this regulatory step and the approval of this naloxone product, and even more so as it is approved for use by 'non-healthcare professionals'. Published evidence and countless anecdotes of personal experience from our peers shows us that many overdoses are witnessed by someone - often a friend or loved one of the overdose casualty. Access to naloxone in these situations can be lifesaving. We believe that opioid drug users and their families and friends should have access to training on overdose intervention, and be offered a supply of a take-home naloxone for use in an emergency situation to reverse a potentially fatal overdose.

We encourage all those affected by opioid use to equip themselves with the knowledge and skills to intervene in an accidental overdose.

The development and approval of a take-home naloxone product marks an important advance in Europe in supporting national and local governments, and harm reduction and recovery programmes to reduce the number of avoidable opioid related overdose deaths."

Prenoxad Injection is a Prescription Only Medicine (POM) containing a solution of naloxone hydrochloride. It is intended for emergency use for the complete or partial reversal of life-threatening respiratory depression following the administration of natural or synthetic opioids. Naloxone is an 'opioid antagonist' medicine with an excellent safety and efficacy profile following use over more than four decades. Prenoxad Injection is a multidose product and is given by intramuscular injection, the only route of delivery proven to be effective in reversing opioid overdoses in a take-home naloxone programme.

View the European Drug Report here: http://www.emcdda.europa.eu/attachements.cfm/att_239505_EN_TDAT15001ENN.pdf

View the World Health Organization publication "Community Management of Opioid Overdose" here:  http://www.who.int/substance_abuse/publications/management_opioid_overdose/en/

About Martindale Pharma®  

Martindale Pharma is a leading UK-based, international specialty pharmaceutical company providing essential medicines to over 28 countries around the world.

Our 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. Our focus is on Opioid Addiction, Emergency Care, Hospital-initiated Medicines, Ophthalmics and Unlicensed Medicines (also called "Specials").

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 (focused on Scandinavia).

Uniquely as an independent pharma company, the business is underpinned by our own modern, efficient UK manufacturing facility which enables us to develop and compete globally to supply high quality, low cost specialty pharmaceuticals in sterile injection and oral liquid formats.

For further information visit our website http://www.martindalepharma.co.uk


Media contacts:
Martindale Pharma        
Michael Clark    
Tel: +44 (0) 1628 551934        

Hume Brophy
Mary Clark, Hollie Vile, Elle Kress
Tel : +44 (0) 207 862 6390

SOURCE Martindale Pharma