* Indivior Announces the Publication of New Data on the Comparative Effectiveness of Intranasal (IN) Nalmefene (OPVEE 2.7mg) and IN Naloxone (4 mg) in a Translational Model Assessing the Impact of a Synthetic Opioid Overdose on Respiratory Depression and Cardiac Arrest
*Large reductions in the incidence of simulated cardiac arrest caused by potentially lethal doses of fentanyl or carfentanil were observed following a single IN dose of OPVEE compared to a single dose of IN naloxone.
*Across scenarios of fentanyl or carfentanil overdoses, simultaneous administration of four doses of IN naloxone (4×4 mg) was needed to reduce the incidence of simulated cardiac arrest to values approaching those obtained with a single dose of OPVEE (3mg). Modeling predictions in chronic opioid users indicate that the incidence of cardiac arrest following an intravenous (IV) fentanyl overdose (2.97 mg) decreased from 78% in the absence of intervention to 12% with OPVEE and 47% with a 4 mg IN dose of naloxone.
Model simulations were performed using a validated translational model1 developed by the
Simulations in opioid naïve individuals illustrated the same trend, although a higher incidence of cardiac arrest was predicted in this population given the lack of tolerance to the respiratory effects of opioids. Simulation of an IV fentanyl overdose (2.97 mg) in opioid naïve individuals led to an incidence of cardiac arrest of 90%, which was reduced to 26% with IN OPVEE and to 68% after 4 mg IN naloxone, respectively.
More than 78,200 fatal opioid overdoses in the US were reported in the one year ending
"These modeling data are relevant considering today's overdose epidemic with increasing prevalence of overdoses from illicitly manufactured synthetic opioids, which can be extremely difficult to reverse6," said
Similar effects were observed following opioid overdose simulations using carfentanil, which is 100-times more potent than fentanyl.8 These trends remain consistent for both chronic and opioid naïve individuals overdosing on carfentanil.
About OPVEE®
OPVEE (nalmefene) nasal spray
INDICATION
OPVEE nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
OPVEE nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
OPVEE nasal spray is not a substitute for emergency medical care.
HIGHLIGHTED SAFETY INFORMATION
CONTRAINDICATIONS
Hypersensitivity to nalmefene or to any of the other ingredients.
WARNINGS AND PRECAUTIONS
Risk of Recurrent Respiratory and Central Nervous System Depression: While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible, therefore, keep patient under continued surveillance and administer repeat doses of OPVEE using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.
Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of nalmefene hydrochloride.
Risk of Opioid Overdose from Attempts to Overcome the Blockade: Attempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may lead to opioid intoxication and death.
ADVERSE REACTIONS
Most common adverse reactions (incidence at least 2%) are nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinalgia, decreased appetite, dysgeusia, erythema, and hyperhidrosis.
For more information about OPVEE and the full Prescribing Information visit www.opvee.com.
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1. Mann J, Samieegohar M, Chaturbedi A, Zirkle J, Han X, Ahmadi SF, Eshleman A, Janowsky A, Wolfrum K, Swanson T, Bloom S, Dahan A, Olofsen E, Florian J, Strauss DG,
2. Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic properties of an FDA-approved intranasal nalmefene formulation for the treatment of opioid overdose. Clin Pharmacol Drug Dev. (2024) 13:58-69. doi: 10.1002/cpdd.1312
3. Ellison M, Hutton E, Webster L, Skolnick P. Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone. J Clin Pharmacol. (2024). doi: 10.1002/jcph.2421
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7. Skolnick, P. (2022). Treatment of overdose in the synthetic opioid era. Pharmacology & Therapeutics, 233, 108019. https://doi.org/10.1016/j.pharmthera.2021.108019
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