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Martindale Pharma® Launches Prenoxad® Injection for the Emergency Treatment of Opioid Overdose


5/3/2013 10:00:24 AM

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Brentwood, May 3 2013: Martindale Pharma, a leader in the manufacture and supply of specialty pharmaceuticals, is pleased to announce the UK launch of Prenoxad Injection, the world’s first licensed emergency treatment for acute opioid related overdose for use at home or other non-medical settings1.

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 decades2.

Prenoxad Injection will be made available to people who are at risk of opioid related overdose or to their nominated client or representative1. It will be administered as part of an emergency resuscitation intervention in suspected overdose casualties and must be used in combination with other basic life support measures. The use of Prenoxad Injection should always be preceded by calling emergency services and requesting an ambulance.

There are more than 1,000 fatal opioid related overdoses in the UK each year alone, with a significant proportion of these being witnessed by other people who use drugs, family members and loved ones. It is recognised that the availability of naloxone at the scene of the overdose can help to reduce this figure2.

The UK Government3, and each of the devolved administrations4,5,6 have identified overdose and drugs related deaths as a significant public health concern and reducing these deaths is a key goal. The provision of naloxone to people at risk of overdose is already underway in Scotland, Wales, and Northern Ireland on a national basis, with many local programmes in existence across England. In May 2012 the Advisory Council on Misuse of Drugs (ACMD) published a report on naloxone including the recommendation that; “Naloxone should be made more widely available to tackle the high numbers of fatal opioid overdoses in the UK”2.

Martindale Pharma has developed Prenoxad Injection following extensive consultation and networking with those responsible for commissioning and delivering outcome focused recovery orientated services, as well as the people who use these services.

Richard de Souza, Chief Executive Officer of Martindale Pharma, commented:

“We are pleased to have launched the world’s first licensed emergency treatment for acute opioid related overdose. More than 1,000 deaths occur each year in the UK as a result of opiate related overdoses and the introduction of Prenoxad Injection marks an important advance in supporting recovery programmes designed to reduce the number of avoidable deaths.”

The Prenoxad Injection pack has been tailored for use by non-healthcare profession individuals in non-clinical settings and comprises of: a yellow translucent plastic box, one pre-filled syringe containing 2ml of 1mg /ml naloxone hydrochloride and two 23G x 1¼ inch needles, inside the box is a Patient Information Leaflet containing product instructions and first aid guidelines appropriate to managing opiate overdose.

In addition to the physical Prenoxad Injection pack, Martindale Pharma fully supports the essential role of education in harm prevention and reduction of opioid overdose and consequently has committed to, and created a platform of educational tools on the safe and effective use of Prenoxad Injection in treating opiate related overdose. Information and educational support materials can be accessed at www.prenoxadinjection.com.

Supplies of Prenoxad Injection will be available to fulfil prescriptions from May 3 2013. Prenoxad Injection will be available exclusively from Alliance Healthcare (Distribution) Limited.

For further information on Prenoxad Injection please contact Martindale Pharma on 0800 0287933 or our Medical Information Team on 01708 382145 or via medinfo@martindalepharma.co.uk.

Notes to healthcare professionals:

Martindale Pharma fully supports the essential role of education in harm prevention and reduction of opioid overdose and consequently has committed to provide a platform of educational tools on the safe and effective use of Prenoxad Injection in treating opiate related overdose in this “high mortality risk” population group.

Product–specific information and educational support materials can be accessed at www.prenoxadinjection.com Prenoxad Injection will be distributed exclusively by Alliance Healthcare (Distribution) Limited.

About Martindale Pharma®

After starting out as a London chemist store owned by William Martindale, Martindale Pharma has remained in business for more than a century and is now firmly established as a leading supplier to the UK’s NHS and exports its products to a number of other major pharmaceutical markets.

In May 2010 AAC Capital bought Martindale Pharma from Cardinal Health. AAC Capital continues to develop the business and pursue growth opportunities.

Martindale Pharma manufacture the majority of their products at their own facilities in the UK, in total producing and packing c.50 million doses a year in a range of formats including sterile ampoules/vials, oral solutions, pre-filled syringes, suppositories and ophthalmics.

Martindale Pharma’s key business segments are:

? Specials

? Critical Care

? Ophthalmics

? Hospital Specialty Products

? Addiction

For further information visit www.martindalepharma.co.uk

Media contacts:

Martindale Pharma

Michael Clark

Tel: +44 (0) 1277 235300

M:Communications

Mary Clark / Amber Bielecka / Hollie Vile

Tel : +44 (0) 207 920 2361

References

1. Prenoxad 1mg/ml Injection Summary of Product Characteristics http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1367213769847.pdf

2. ACMD Consideration of Naloxone May 2012 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/119120/consideration-of-naloxone.pdf

3. HM Government DRUG STRATEGY 2010-Reducing demand, restricting supply, building recovery: Supporting people to live a drug free life https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/98026/drug-strategy-2010.pdf

4. New Strategic Direction for Alcohol and Drugs Phase 2 2011-2016 http://www.dhsspsni.gov.uk/new_strategic_direction_for_alcohol_and_drugs_phase_2__2011-2016_

5. Working Together to Reduce Harm The Substance Misuse Strategy for Wales 2008-2018 http://wales.gov.uk/dsjlg/publications/commmunitysafety/strategy/strategye.pdf;jsessionid=623EAB9C717D3861A106A5B3E71DA604?lang=en

6. Scottish Government- ‘Road to Recovery’ 2008 http://www.scotland.gov.uk/Topics/Justice/law/Drugs-Strategy

Prescribing information for Prenoxad 1mg/ml Injection

Please refer to Summary of Product Characteristics before prescribing.

Presentation: A 2ml pre-filled syringe containing Naloxone Hydrochloride 1mg/ml.

Indications: Prenoxad Injection is intended for emergency use in the home or other non-medical setting by appropriate individuals or in a health facility setting for the complete or partial reversal of respiratory depression induced by natural and synthetic opioids, including methadone, diamorphine (diacetylmorphine (INN)) and certain other opioids such as dextropropoxyphene and certain mixed agonist/antagonist analgesics: nalbuphine and pentazocine.

Prenoxad Injection should be carried by persons at risk of such events.

It may also be used for the diagnosis of suspected acute opioid overdose.

Dosage and Administration: Prenoxad Injection may only be made available once the prescriber has assessed the suitability and competence of a client or representative to administer naloxone in the appropriate circumstances. Prenoxad Injection is for administration by intramuscular injection.

Adults and the Elderly: Opioid overdosage (known or suspected). For Use by individuals in the community In patients where breathing does not appear to be normal.

In patients where breathing does not appear to be normal administration of Prenoxad Injection should be preceded by calling emergency services and requesting an ambulance. Following this, 30 chest compressions and if possible 2 rescue breaths (Basic Life Support SINGLE CYCLE) should be given; 0.4ml Prenoxad Injection solution should then be administered by intramuscular injection into the outer thigh muscle or muscles of the upper arm, through clothing if necessary. A further 3 cycles of chest compressions and rescue breaths should then be given followed by administration of 0.4ml Prenoxad Injection. Three cycles of chest compression and rescue breaths should take approximately 2 minutes. This should be repeated until an ambulance arrives or the patient begins breathing normally / regains consciousness. The patient when breathing normally or has regained consciousness should be placed in the recovery position (lying on their side, mouth open pointing towards the ground) and observed continuously.

In patients were breathing is normal but the patient is unrousable or suspected to be unconscious. The patient should be placed in the recovery position. 0.4ml Prenoxad Injection solution should be administered by intramuscular injection into the outer thigh muscle or muscles of the upper arm, through clothing if necessary, and an ambulance should be called. 0.4ml Prenoxad Injection solution should then be administered every 2-3 minutes and continued until the ambulance arrives and or the patient regains consciousness.

Children and Neonates: The Prenoxad Injection presentation is not intended to be used for children in the home setting other than by an appropriately trained healthcare professional.

Contra-Indications: Known hypersensitivity to Naloxone or any of the ingredients.

Warnings and Precautions: Prenoxad Injection is intended as an emergency treatment and the patient should be advised to seek medical help immediately. It should be administered cautiously to patients who have received large doses of opioids or to those physically dependent on opioids since too rapid reversal of opioid effects by Prenoxad may precipitate an acute withdrawal syndrome in such patients.

Patients who have responded satisfactorily to Prenoxad should be kept under medical observation for at least 2 hours. Repeated doses of Prenoxad may be necessary since the duration of action of some opioids may exceed that of Prenoxad. Use with caution in patients with pre-existing cardiac, hepatic or renal disease and in those receiving medications with potential adverse cardiovascular effects e.g. hypotension, ventricular tachycardia or fibrillation and pulmonary oedema. Caution should be exercised and patients monitored when Prenoxad Injection is administered to this patients with renal insufficiency/failure or liver disease.

Interactions: Administer cautiously to opioid dependent patients including newborns of mother’s dependant or those suspected of having received large doses and observe for signs of acute withdrawal.

Pregnancy and Lactation: Prenoxad should be used with caution in pregnancy. The neonate must also be monitored for signs of opioid withdrawal. Naloxone may be administered during the second stage of labour to correct any respiratory depression due opioid analgesics. It is not known whether Naloxone is excreted in human milk therefore use with caution in breastfeeding mothers.

Undesirable Effects: Common side effects include nausea, vomiting, dizziness, headache, ventricular tachycardia, hypotension and hypertension. Less common side effects: Tremor, sweating, arrhythmia, bradycardia, diarrhoea, dry mouth, hyperventilation, inflammation. Seizure tension, allergic reactions, anaphylactic shock, fibrillation, cardiac arrest, erythema multiforme, fever, dyspnoea, runny nose, sneezing and yawning. Piloerection, weakness, shivering. Product Licence Number: PL 12064/0125 Product Licence Holder: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex RM3 8UG Basic NHS Price: £18.00 Legal Category: POM. Date of Preparation: April 2013

For more details contact:

Aurum Pharmaceuticals

Hubert Road, Brentwood, Essex CM14 4LZ

01277 266600

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 Martindale Pharma Tel. 01277 266600 Fax 01708 382739 e-mail drugsafety@martindalepharma.co.uk



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