Indivior | Indivior Statement on the Availability of OPVEE® (nalmefene) Nasal Spray

Indivior announces the availability of OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid 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 . Effective October 2, 2023, orders begin shipping to customers. Reference: 1. 1 www.opvee.com About OPVEE® (nalmefene) Nasal Spray 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. Hypersensitivity to nalmefene or to any of the other ingredients. 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. 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. 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. 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. 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 INDICATION HIGHLIGHTED SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Risk of Recurrent Respiratory and Central Nervous System Depression: Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists: Precipitation of Severe Opioid Withdrawal: Risk of Cardiovascular (CV) Effects: Risk of Opioid Overdose from Attempts to Overcome the Blockade: 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 . ADVERSE REACTIONS OPVEE.com

The release as fetched from its publisher. indivior.com ↗