FDA approves prescription nasal spray for opioid overdose treatment
The US Food and Drug Administration (FDA) has announced that it has approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdose in adults and paediatric patients over the age of 12.
The drug, when administered quickly, can reverse the effects of opioid overdose, including respiratory depression, sedation and low blood pressure, with this product providing 2.7mg of nalmefene into the nasal cavity. It is available by prescription and intended for use in healthcare and community settings.
Opvee’s approval follows various safety and pharmacokinetic studies, as well as a study that assessed how fast the drug worked in people who use opioids recreationally. Some adverse reactions were reported, these included nasal discomfort, headaches, nausea, dizziness, hot flushes, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose, decreased appetite, skin redness and excessive sweating.
It was also noted that the use of nalmefene hydrochloride in patients who are opioid dependent can result in opioid withdrawal, including symptoms such as body aches, diarrhoea, fast heart rate, runny nose, fever, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
Robert M Callif MD, FDA commissioner, commented: “The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products. On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmafene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders.”
Pharmaceutical Industry news, analysis and insights