RT’s Three Key Takeaways:
- Comparative Effectiveness: The examine discovered that intramuscular nalmefene reversed opioid-induced respiratory despair as successfully as naloxone, with an extended period of motion.
- Speedy Onset: Each intramuscular nalmefene and naloxone reversed respiratory despair inside 5 minutes, quicker than intranasal naloxone.
- Security Profile: Opposed occasions have been reported throughout all remedy teams however have been typically delicate and didn’t result in examine discontinuation, supporting nalmefene’s security on this setting.
Purdue Pharma introduced findings from a examine in wholesome grownup volunteers that demonstrated in a medical mannequin of opioid-induced respiratory despair that intramuscular nalmefene (1 mg) reversed fentanyl-induced respiratory despair much like or higher than intramuscular naloxone and intranasal naloxone.
The findings are revealed in The Journal of Medical Pharmacology. Imbrium Therapeutics LP, a subsidiary of Purdue, sponsored the examine.
Nalmefene hydrochloride injection is an opioid antagonist indicated for the entire or partial reversal of opioid drug results, together with respiratory despair, induced by both man-made or natural opioids and within the administration of recognized or suspected opioid overdose.
Nalmefene hydrochloride injection is contraindicated in sufferers with a recognized hypersensitivity to the product. Nalmefene has the identical pharmacological mechanism of motion as naloxone. Nalmefene has a protracted period of motion and gives one other remedy possibility in reversing overdoses, together with overdoses ensuing from excessive doses of potent, long-acting artificial opioids.
Whereas nalmefene has a protracted period of motion, well being care suppliers must be conscious {that a} recurrence of respiratory despair is feasible.
Options to Deal with Opioid Disaster
Purdue Pharma distributes, for no revenue, nalmefene injection in a 2mg/2mL (1mg/1mL) vial as a part of the corporate’s dedication to offering opioid overdose therapies that may assist save lives in communities throughout the nation.
“As an R&D-driven pharmaceutical firm, we’re dedicated to delivering options to assist tackle the opioid disaster and conducting analysis to contribute to the rising physique of scientific information about opioid antagonists,” says Craig Landau, MD, president and CEO, Purdue Pharma, in a information launch. “Research like this are necessary to assist advance our collective information and construct understanding of how nalmefene might help deal with opioid overdoses.”
Investigating Nalmefene and Naloxone
This replicate design, crossover examine, utilizing an opioid-induced respiratory despair mannequin, investigated the onset and time plan of action of nalmefene and naloxone in reversing the results of fentanyl-induced respiratory despair outlined as a discount in respiratory minute quantity.
A 3-step fentanyl infusion was administered to soundly obtain after which keep fentanyl concentrations adequate to trigger respiratory despair in opioid-induced respiratory despair. After fentanyl-induced respiratory despair was established, wholesome grownup contributors aged 18-55, with a historical past of current nonmedical opioid publicity, have been randomized to obtain intramuscular nalmefene 1 mg, intramuscular naloxone 2 mg, or intranasal naloxone 4 mg. The time course of reversal was monitored for 90 minutes following antagonist administration.
Minute quantity profiles confirmed that onset of reversal of fentanyl-induced respiratory despair occurred throughout the first 5 minutes following antagonist administration for all three therapies. Nevertheless, the onset of reversal was earlier for intramuscular nalmefene and intramuscular naloxone, in comparison with intranasal naloxone.
As well as, in keeping with nalmefene’s half-life, the period of reversal was longer with nalmefene, and the imply minute quantity was maintained at the next stage by means of the top of the reversal session at 90 minutes following antagonist administration.
All contributors skilled treatment-related hostile occasions (TEAEs), however none have been extreme, critical, or led to review drug discontinuation, and TEAEs have been comparable in all three remedy arms. Probably the most generally reported TEAEs by topics within the examine included hyperhidrosis (intramuscular nalmefene, 25%; intramuscular naloxone, 0%; intranasal naloxone, 12.5%); nausea (intramuscular nalmefene, 25.0%; intramuscular naloxone, 12.5%; intranasal naloxone, 0); and vomiting (intramuscular nalmefene, 12.5%; intramuscular naloxone, 12.5%; intranasal naloxone, 12.5%).
Examine Limitations and Implications
Examine limitations embody the modest pattern measurement, which was partially mitigated by administering every remedy twice, with the 2 administrations producing constant outcomes. One other limitation is that fentanyl concentrations have been maintained roughly fixed, which might not be anticipated to happen in a real-world setting. Additional, pharmacodynamics have been solely analyzed as much as 90 minutes after opioid antagonist administration, which meant that the period of reversal couldn’t be assessed past this level.
“Though the [opioid-induced respiratory depression] mannequin isn’t a simulation of real-world opioid overdoses, it permits the magnitude and time course of reversal of fentanyl-induced respiratory despair to be instantly in contrast between opioid antagonists,” says Sailaja Bhaskar, PhD, MBA, vp of medical R&D of Imbrium Therapeutics, in a launch. “Further research and evaluation of real-world information will additional inform how nalmefene could be included into opioid overdose remedy protocols.”
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