Patients and Caregivers

Priorities for Collaborative Research

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

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 a naloxone infusion to manage opioid overdose in Emergency Department (ED)/hospital settings
Methods Retrospective evaluation of information extracted from electronic health records (EHR)
Key Outcome Variables
  • Frequency of naloxone infusion
  • Length of infusion (time), infusion rate, and total dose administered
  • Patient Outcomes (e.g., reversal, recurrence of respiratory depression, hospital admission, discharge)
  • Opioids known or suspected to have contributed to the overdose
Basic Research Requirements
  • Institution use of naloxone infusion to treat opioid overdoses; ideally a minimum of 100 cases between 2016 and the present

Withdrawal symptoms following administration of opioid overdose reversal agent in emergency care settings

Objectives To assess the frequency of precipitated withdrawal symptoms following opioid overdose reversal agent administration and treatment options used to manage those symptoms
Methods Retrospective evaluation of information extracted from electronic health records (EHR)
Key Outcome Variables
  • Frequency of various symptoms commonly associated with opioid withdrawal brought on by administration of opioid overdose reversal medicine
  • Severity of the symptoms, if available, and treatment used, if any
  • Patient Outcomes (e.g., reversal or recurrence of respiratory depression, hospital admission, discharge)
Basic Research Requirements
  • Withdrawal information documented in EHR systems

Patient outcomes following administration of Nalmefene HCl Injection for treatment of opioid overdose

Objectives To assess the frequency of successful reversal of respiratory depression following the administration of Nalmefene HCl Injection in ED or EMS settings; and the dosage associated with those reversals
Methods Observational cohort study with analysis of data extracted from electronic health records (EHR)
Key Outcome Variables
  • Patient Outcomes (i.e., reversal, recurrence of respiratory depression, hospital admission, discharge)
  • Antagonist dosages administered (including route of administration, repeat dosages, pre-hospital use of naloxone)
  • Presence of withdrawal symptoms and treatments used to address these 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 per their clinical judgment
Given today’s opioid overdose environment, we are interested in hearing ideas for other research topics that may explore patient outcomes following the administration of Nalmefene HCl Injection.

Important Information About Nalmefene HCl Injection

Nalmefene HCl Injection, a sterile solution containing 2 mg/2 mL (1 mg/mL) in vial form for intravenous, intramuscular, and subcutaneous injection, was FDA approved in February 2022.

Indications and Usage
Nalmefene HCl Injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene HCl Injection is indicated in the management of known or suspected opioid overdose.1

Contraindications
Nalmefene HCl Injection is contraindicated in patients with a known hypersensitivity to the product.1

Warnings and Precautions
Nalmefene HCl Injection is associated with the following Warnings and Precautions: Use of Nalmefene in Emergencies, Risk of Recurrent Respiratory Depression, Cardiovascular Risks with Narcotic Antagonists, Risk of Precipitated Withdrawal, Incomplete Reversal of Buprenorphine, and Use in Pediatric Patients. Patients treated with nalmefene HCl injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.1

Adverse Events
The most common adverse reactions (>1%) reported in clinical trials with Nalmefene HCl Injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%).1

Please consult the Nalmefene HCl Injection Full Prescribing Information available here 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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