Beyond Narcan: Opvee is the Next Generation Opioid Overdose Reversal for Law Enforcement
Bottom line up front: Opvee is a new and improved Narcan. It lasts much longer than Narcan and can be beneficial to officers working the streets or narcotics.
In a significant stride towards enhanced opioid overdose intervention, the FDA has recently approved a new form of overdose reversal agent - nalmefene hydrochloride nasal spray, commercially known as Opvee. This novel medication offers a critical advantage over existing treatments: it boasts a significantly longer-lasting effect than the widely-used naloxone, making it a more durable countermeasure against opioid overdoses.
Opvee: The Long-Lasting Answer to Opioid Overdoses
The FDA's endorsement of Opvee marks the debut of the first nalmefene hydrochloride opioid reversal agent, positioning it as a potent tool in the face of the ongoing opioid crisis. The longevity of this new medication is its standout feature, with a plasma half-life of around 11 hours, compared to approximately 2 hours for naloxone. This extended duration aligns more closely with the action of most opioids, offering a potentially life-saving solution during opioid overdose emergencies.
A New Addition to the FDA Overdose Prevention Framework
The FDA's decision to greenlight Opvee is in line with its overarching Overdose Prevention Framework. This framework is designed to support harm reduction strategies and the development of innovative overdose reversal products. With the approval of nalmefene nasal spray, a new prescription opioid antagonist option is now available to law enforcement, first responders and other medical personnel.
Addressing a Public Health Crisis
The advent of the nalmefene nasal spray comes at a crucial moment when drug overdose continues to be a significant public health issue in the U.S. Synthetic opioids, such as fentanyl, were the primary cause of more than 105,000 reported fatal overdoses in 2022, highlighting the need for effective intervention strategies. With 66% of all M30 fentanyl pills being a lethal dose, Opvee comes at an opportune time.
The Science Behind Nalmefene
The approval of nalmefene was underpinned by comprehensive safety and pharmacokinetic studies. These studies revealed that the time to onset of reversal of respiratory depression was observed between 2.5 to 5 minutes, with full recovery of respiratory drive manifesting as early as 5 minutes after nalmefene administration.
Potential Side Effects and Usage Guidelines
Users should be aware of potential adverse reactions, which can include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, and throat irritation, among others.
The developers, Indivior, also caution that nalmefene use could be followed by a recurrence of respiratory depression. Therefore, recipients should be monitored continuously and given repeat doses as necessary while awaiting professional medical assistance. Larger or repeat doses may also be required to completely reverse the effects of specific opioids, including buprenorphine and pentazocine.
Availability and Distribution
Opvee is expected to hit the market in the Q4 of 2023, making it a readily accessible tool in the hands of law enforcement agencies.
The U.S. Food and Drug Administration (FDA) has made concerted efforts to support the development of novel overdose reversal products as part of their Overdose Prevention Framework. This commitment is aimed at bolstering harm reduction initiatives and placing life-saving tools like Opvee directly into the hands of those who can make the most immediate use of them - communities, harm reduction groups, and emergency responders, including law enforcement agencies.
Specific strategies for distributing Opvee to law enforcement agencies nationwide have not been disclosed as of the time of this writing. However, the goal is clear: to ensure that this new prescription opioid antagonist option is readily available whenever and wherever it is needed to combat the ongoing opioid crisis. Future updates will provide more specific details about distribution strategies and logistics.
In anticipation of the release of Opvee into the market, it is recommended that law enforcement agencies begin discussions on training protocols to ensure that all members are adequately trained on the use of this potentially life-saving drug. This would ensure readiness once the drug becomes available.
Looking Forward
With the approval of nalmefene and its anticipated availability in the last quarter of 2023, a critical step forward has been taken in tackling the opioid crisis. While this development alone cannot resolve the ongoing issue, it equips communities and emergency responders with another vital tool to manage and potentially prevent fatal opioid overdoses.
With this recent approval, the FDA continues to demonstrate its commitment to reducing the impacts of the opioid crisis. This progress shows that, through ongoing research, development, and collaboration, new solutions can be found to address this significant public health challenge. As law enforcement professionals, it is crucial to stay informed of these advancements and understand how they can be incorporated into our practices to ensure the safety and well-being of the communities we serve.
At the end of the day, the goal is simple: to save lives. This includes your life. By all appearances, this new opioid reversal agent is a great tool for law enforcement officers that may become exposed to synthetic opioids. The approval of nalmefene brings us one step closer to that goal, providing a new, powerful tool in the battle against opioid overdoses. The future of opioid crisis management is here, and it's found in a nasal spray.
Q: What is nalmefene hydrochloride?
A: Nalmefene hydrochloride is an opioid antagonist used for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. It works by binding to the opioid receptor and blocking the effects of the narcotic.
Q: What is nalmefene hydrochloride injection?
A: Nalmefene hydrochloride injection is an injectable form of nalmefene hydrochloride used for the treatment of and opioid overdose. It is also used in the management of opioid overdose in postoperative and pediatric patients.
Q: What is the difference between nalmefene hydrochloride and naltrexone?
A: Nalmefene hydrochloride and narcan are both opioid antagonists, but nalmefene hydrochloride has a longer duration of action than narcan.
Q: What is the use of nalmefene hydrochloride injection?
A: 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. It is also used in the management of known or suspected opioid overdose in postoperative and pediatric patients.
Q: What are the risks associated with the use of this new reversal agent?
A: The use of nalmefene hydrochloride injection may precipitate withdrawal in patients with physical dependence on opioids. It may also cause tachycardia, cardiovascular effects, and recurrent respiratory depression in patients treated with nalmefene injection.
Q: How is it injection administered?
A: Nalmefene hydrochloride injection is administered by a healthcare professional as a single intravenous or intramuscular injection.
Q: What is the recommended dose?
A: The recommended initial dose of nalmefene hydrochloride injection is 0.1 mg/kg body weight, administered as a single intravenous or intramuscular injection. Repeat doses may be given every 2-3 minutes as needed.
Q: What are the benefits of using this drug over other opioid antagonists?
A: Studies have shown that nalmefene hydrochloride injection has a longer duration of action than other opioid antagonists, such as naloxone and naltrexone, making it more effective in the treatment of known or suspected opioid overdose.
Q: Is it safe for use in children?
A: The safety and effectiveness of nalmefene hydrochloride injection in children have not been established.
Q: Who manufactures this drug?
A: Nalmefene hydrochloride injection is manufactured by Purdue Pharma.
"This novel medication offers a critical advantage over existing treatments .."
Nalmefene is hardly novel, having first been approved in USA (Revex brand). It's chemical structure is very similar to naltrexone (approved 1984), and their mechanisms of action are identical.
Only the duration of action differs.
The nasal spray formulation was approved in May 2023.
Your, "Who manufactures this drug?" question/answer suggests that you don't even read what you type
"Q: Who manufactures this drug?
A: Nalmefene hydrochloride injection is manufactured by Purdue Pharma."
That's correct.
But Opvee brand nalmefene nasal spray is made (or at least marketed) by Indivior, Inc.
Purdue was not involved.