Nyxoid registered to tackle life-threatening risks from opioid overdose

+Undoctored

Nyxoid registered to tackle life-threatening risks from opioid overdose

Media release from Pharmaco Emergency Care
1 minute to Read
Undoctored_brown

The single-dose nasal spray, Nyxoid®, has been registered in New Zealand for use in emergency treatment for potentially life-threatening opioid overdoses.

The product will be available to frontline services who may encounter life threatening overdose situations while undertaking their duties.

Opioids such as morphine, codeine, tramadol and fentanyl are highly effective pain relievers and are being used increasingly, but have risks of overdose and potential addiction.

The use of Fentanyl in New Zealand more than doubled between 2011 and 2016, there was almost a 50% increase in morphine dispensed, and opioid overdose led to the death of 170 people between 2008 and 2012.

Nyxoid® contains naloxone, a drug that temporarily reverses the effect of opioids to provide enough time for emergency services to arrive and administer further care. Its constituent naloxone works by attaching itself strongly to the opioid receptors in the brain and body, so strongly that it temporarily reduces the effect of the opioids. Simply put, naloxone allows the brain to wake up and keep the person breathing.

Naloxone, in its injectable form, has been widely used in emergency medicine since the 1970s both in pre-hospital and hospital settings.

Nyxoid® is distributed in New Zealand by healthcare company Pharmaco Emergency Care.

Pip Cotterell of Pharmaco Emergency Care says:

“Nyxoid’s arrival in New Zealand is a response to the many calls to have Naloxone more available to potentially save lives, following an accidental or intentional overdose. Having it in an easy-to-use dispenser is a real break-through."

The single dose Nyxoid® nasal spray is quick and easy to use, enables rapid absorption intra-nasally and bypasses the challenges of administering an injection by non-medically trained people. No priming is needed and it can be used by anyone following the clear instructions on the applicator.

Nyxoid® is not a substitute for professional healthcare. Always call an ambulance before using Nyxoid®.

PreviousNext
References

MANDATORIES

NYXOID® - naloxone hydrochloride dehydrate - PRESCRIPTION MEDICINE

Presentation: NYXOID® is a nasal spray containing 1.8mg 1.8 mg naloxone (as hydrochloride dihydrate).

Indications: NYXOID is intended as part of the emergency treatment for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. NYXOID is indicated in adults and adolescents aged 14 years of age and over.

Contraindications: Hypersensitivity to the active substance or to any of the excipients (naloxone, sodium citrate dehydrate, sodium chloride, hydrochloric acid, sodium hydroxide, purified water)

Special warnings and precautions for use: NYXOID should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established. NYXOID is not a substitute for emergency medical care and may be used instead of intravenous (IV) injection, when IV access is not immediately available. The importance of seeking medical assistance: NYXOID is intended as part of an emergency treatment and the patient/carer should be advised to seek medical help immediately. Monitoring of the patient for a response: Patients who respond satisfactorily to naloxone must be closely monitored. The effect of some opioids can be longer than the effect of naloxone which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required. Opioid withdrawal syndrome: Receiving naloxone can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome in such patients. Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when naloxone is administered. Effectiveness of naloxone: Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs respiration should be mechanically assisted. Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects. Paediatric population: Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes. Pregnancy: There are no adequate data from the use of naloxone in pregnant women. Breastfeeding: It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone.

Interactions: Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists. When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals. Hypertension, cardiac arrhythmias, pulmonary oedema and cardia arrest have been described, more typically when naloxone is used post-operatively. Administration of NYXOID may decrease the analgesic effects of opioids used primarily to provide pain relief, due to its antagonistic properties.

Dose and administration: Nasal use only. NYXOID spray should be administered as soon as possible to avoid damage to the central nervous system or death. NYXOID contains only one dose and therefore it must not be primed or tested prior to administration. The device is ready for use. If an overdose is suspected, call for emergency medical assistance immediately. NYXOID is NOT a substitute for emergency medical care.

Adverse Effects: Very Common: Nausea. Common: Dizziness, Headache, Tachycardia, Hypotension, Hypertension, Vomiting. Uncommon: Tremor, Arrhythmia, Bradycardia, Hyperventilation, Diarrhoea, Dry mouth, Hyperhidrosis, Drug withdrawal syndrome (in patients dependent on opioids). Very Rare: Hypersensitivity, Anaphylactic shock, Cardiac fibrillation, Cardiac arrest, Pulmonary oedema, Erythema multiforme

Pharmaco (NZ) Ltd, Auckland. Data Sheet Feb 2019

Prior to prescribing or for further information please consult the manufacturer’s full data sheet available at www.medsafe.govt.nz.

For Consumers: Nyxoid is a PRESCRIPTION MEDICINE. Use strictly as directed. If symptoms continue or you have side effects, see your doctor, pharmacist or healthcare professional. Further information on the risks and benefits of this medicine please contact your doctor, pharmacist or healthcare professional or access the Consumer Medicines Information available at www.medsafe.govt.nz

References:

https://www.hqsc.govt.nz/our-programmes/health-quality-evaluation/projects/atlas-of-healthcare-variation/opioids/

https://www.nzdoctor.co.nz/article/undoctored/how-new-zealand-can-avoid-us-type-opioid-crisis

TAPS DA1926IM