HEALTHCARE PROFESSIONALS

Collaborative Research Initiatives

The Purdue Pharma L.P. Medical Affairs department is pursuing collaborative research to better understand opioid overdose reversal and to inform future research to advance patient care.

For more information or if interested in collaborating on any of the research topics described below, please contact Purdue Medical Information at 888-726-7535, option 1 or via email at PurdueMedInfo@pharma.com

Recently Completed Research

Clinical Outcomes from Injectable Nalmefene in the Emergency Department (COINED)

Study Location UC San Diego Health and El Centro Regional Medical Center (California)
Objectives To assess the utilization of nalmefene HCl injection for the treatment of known or suspected acute opioid toxicity in the ED setting; and the dosage(s) associated with those reversals
Methods Retrospective observational study of electronic health records (EHR)
Key Outcome Variables
  • Patient Outcomes (e.g., hospital admission, discharge, frequency of multiple antagonist administrations)
  • Nalmefene dosages administered
  • Naloxone dosages administered (including any pre-hospital administrations)
  • Frequency of precipitated withdrawal symptoms

https://​www​.purduepharma​.com/​n​e​w​s​/​2​0​2​4​/​0​9​/​3​0​/​s​t​u​d​y​-​e​x​a​m​i​n​i​n​g​-​u​s​e​-​o​f​-​n​a​l​m​e​f​e​n​e​-​h​c​i​-​i​n​j​e​c​t​i​o​n​-​f​o​r​-​o​p​i​o​i​d​-​o​v​e​r​d​o​s​e​-​r​e​v​e​r​s​a​l​-​i​n​-​e​m​e​r​g​e​n​c​y​-​d​e​p​a​r​t​m​e​n​t​s​-​c​o​n​c​l​u​d​e​s​-​o​b​s​e​r​v​a​t​i​o​n​a​l​-​p​e​riod/

Attitudes Toward use of Auto-Injectors During a Medical Emergency

Objectives To measure attitudes among non-medical personnel regarding the use of auto-injectors and nasal sprays during a medical emergency involving an opioid overdose.
Methods Surveys of general U.S. population, including people with an increased likelihood of providing emergency resuscitation during an opioid overdose.
Key Outcome Variables
  • Willingness and comfort-level using auto-injectors and nasal sprays
  • Attitudes toward using these devices with loved ones, colleagues and strangers

Research Studies Currently In-Progress

Use of Naloxone Infusion to Treat Opioid Overdose in Hospital Settings

Objectives To systematically document the clinical characteristics and resource utilization associated with the use of naloxone infusion to manage opioid overdoses in ED/hospital settings
Methods Retrospective evaluation of electronic health records (EHR)
Key Outcome Variables
  • Frequency of naloxone infusion
  • Length (time) of infusion, infusion rate, and total dose administered
  • Patient Outcomes (e.g., recurrence of respiratory depression, hospital admission, discharge)
  • Opioids known or suspected to have contributed to the overdose

Current Research Interests

Patient Outcomes Following Administration of Nalmefene HCI Injection for Treatment of Opioid Overdose

Objectives To assess the reversal of respiratory depression following the administration of nalmefene HCl injection in ED or EMS settings
Methods Observational cohort study of patients who are administered nalmefene HCl injections as part of treatment for a known or suspected opioid overdose
Key Outcome Variables
  • Patient Outcomes (e.g., reversal, recurrence of respiratory depression, hospital admission, discharge)
  • Antagonist dosages administered (including any use of naloxone)
  • Presence of precipitated withdrawal, and any treatments administered to address withdrawal symptoms
  • Opioids known or suspected to have contributed to the overdose
Basic Research Requirements
  • Nalmefene HCl injection on formulary and available to ED and/or EMS personnel
  • HCP can administer nalmefene HCL injection per their clinical judgment

Hospital Emergency Department (ED) Experience with Nalmefene HCl Injection

Objectives
  • To assess the utilization of nalmefene HCl injection for the treatment of known or suspected acute opioid toxicity in the ED setting; and the dosage(s)
  • To understand the clinical decision making associated with those reversals
Methods
  • Retrospective observational study of electronic health records (EHR)
  • Survey of clinicians in the ED responsible for those opioid overdose reversals to understand clinical rationale for the choice of opioid reversal antagonist
Key Outcome Variables
  • Patient Outcomes (e.g., recurrence of respiratory depression, hospital admission, discharge)
  • Nalmefene dosages administered
  • Naloxone dosages administered (including any pre-hospital administrations)
  • Frequency of precipitated withdrawal symptoms
  • Clinician survey results
Basic Research Requirements
  • Nalmefene HCl injection on formulary and available to ED and/or EMS personnel
  • HCP can administer nalmefene HCL injection per their clinical judgment
IMPORTANT SAFETY INFORMATION AND INDICATION ABOUT NALMEFENE HCL INJECTION

CONTRAINDICATION
Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.

WARNINGS AND PRECAUTIONS

Use of Nalmefene Hydrochloride injection in Emergencies
Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.

Risk of Recurrent Respiratory Depression
Accidental overdose with long-acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment.

Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.

Cardiovascular Risks with Narcotic Antagonists
Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects.

Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs.

Risk of Precipitated Withdrawal
Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications.

Incomplete Reversal of Buprenorphine
Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphine-induced respiratory depression.

Use in Pediatric Patients
Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.

ADVERSE REACTIONS
The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%).

INDICATIONS AND USAGE
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Please consult the Nalmefene HCl Injection Full Prescribing Information provided for complete product information.

For more information, please contact Purdue Medical Information at 888-726-7535, option 1 or via email at PurdueMedInfo@pharma.com

Reference

  • Nalmefene HCl Injection [Full Prescribing Information]. Stamford, CT: Purdue Pharma L.P.
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