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Last updated on April 20, 2014 at 17:20 EDT

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

May 3, 2013

BRENTWOOD, England, May 3, 2013 /PRNewswire/ –

        - World's first licensed naloxone product for use by non-healthcare
          profession individuals in a community setting
        - Prenoxad Injection is a pre-filled syringe containing 1mg/ml naloxone
          hydrochloride solution for injection

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 UK2.”

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 11/4
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 http://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.

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

http://www.prenoxadinjection.com

Prenoxad Injection will be distributed exclusively by Alliance Healthcare
(Distribution) Limited.

Notes to editors:

About Martindale Pharma(R)

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 [http://martindale.pslink.org.uk/products/specials ]
        - Critical Care [http://martindale.pslink.org.uk/products/critical-care ]
        - Ophthalmics [http://martindale.pslink.org.uk/products/ophthalmics ]
        - Hospital Specialty Products
          [http://martindale.pslink.org.uk/products/hospital-specialty ]
        - Addiction [http://martindale.pslink.org.uk/products/substance-abuse ]

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

        1) 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

        2) 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_

        1) 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

        1) 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 where 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: GBP18.00 Legal Category: POM. Date of Preparation: April 2013

For more details contact: Aurum Pharmaceuticals

Hubert Road, Brentwood, Essex CM14 4LZ

+44(0)1277-266600

Adverse events should be reported. Reporting forms and information can be found at
http://www.mhra.gov.uk/yellowcard. Adverse events should also be reported to

Martindale Pharma Tel. +44(0)1277-266600 Fax +44(0)1708-382739 e-mail
drugsafety@martindalepharma.co.uk

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

For further information on Prenoxad Injection please contact Martindale Pharma on
+44(0)800-0287933 or our Medical Information Team on +44(0)1708-382145 or via
medinfo@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

SOURCE Martindale Pharma


Source: PR Newswire