HQ Team
May 23, 2023: The FDA cleared Opiant Pharmaceuticals’ nasal spray to treat opioid overdose in adult and paediatric patients under the regulator’s priority review designation.
This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use, according to a statement from the regulator.
A priority review designation means FDA’s goal is to take action on an application within six months, compared to 10 months under standard review.
Opvee, is the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older, according to the statement.
Synthetic opioids
Drug overdose is a major public health issue in the US, with more than 103,000 reported fatal overdoses occurring in the 12-month period ending in November 2022, primarily driven by synthetic opioids like illicit fentanyl.
The nasal spray will expand the treatment options in patients and in an emergency, it stated.
“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,” said FDA Commissioner Robert M. Califf, M.D.
“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.”
Opioid receptor antagonist
Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure (hypotension).
Opvee delivers 2.7 milligrams (mg) of nalmefene into the nasal cavity and is available by prescription. It is intended for use in health care and community settings.
The approval of Opvee was supported by safety and pharmacokinetic studies, as well as a study on people who use opioids recreationally to assess how quickly the drug works, the USFDA stated.
The most common adverse reactions include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose, decreased appetite, skin redness and excessive sweating.
The use of nalmefene hydrochloride in patients who are opioid-dependent may result in opioid withdrawal characterized by body aches, diarrhea, fast heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
Overdose reversal
The FDA’s Overdose Prevention Framework consists of four priorities — encouraging harm reduction through efforts to increase availability and expand access to overdose reversal products.
Nalmefene, is an opioid receptor antagonist that provides fast onset and long-duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death, according to a company statement.
“Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl,” said Mark Crossley, CEO, Indivior.
“Opvee is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives.”
Following Opvee administration, the time to onset of reversal of respiratory depression was observed between 2.5 to five minutes. A full recovery of the respiratory drive was manifested as early as five minutes, according to the company statement.
Acquisition
Opvee is expected to be in the market in the fourth quarter of this year.
Indivior acquired Opiant Pharmaceuticals Inc. and closed the transaction on March 2, 2023.
Indivior forecast that Opvee has the potential for this treatment to deliver annual net revenue of $150 million to $250 million, with expected earnings accretion from the Opiant acquisition after the second full year of unveiling Opvee in the market.
Indivior, a global pharmaceutical company develops medicines to treat substance use disorders and serious mental illnesses.
