1961, Dr. Jack Fishman and Dr. Mozes Lewenstein applied for one of the first patents for naloxone.
1971, the Food and Drug Administration (FDA) approved using naloxone to treat overdoses.
1995, the FDA has granted OxyContin drugmaker Purdue Pharma, fast track designation for opioid overdose antidote Revex nalmefene hydrochloride (HCl) injection. However, the besieged firm has vowed not to profit from sales of the drug. US firm Baxter’s version of the drug was previously approved as an antidote for opioid overdoses in 1995.
2008, sold under the brand name Revex, the drug was discontinued, due in part to poor sales. As such, Purdue’s version is not likely to be a major money maker for the firm.
2012, the FDA, the Center for Drug Evaluation and Research, the Office of the Assistant Secretary for Health, National Institutes of Drug Abuse, and the Centers for Disease Control and Prevention (CDC) sponsored a public discussion on the potential value of making naloxone more widely available to reduce the incidence of opioid overdose fatalities. The majority of individuals participating in the program were in support of an over-the-counter (OTC) approval of naloxone. (Bastianelli & Orr, 2014)
2018, injection nalmefene is approved by the FDA for opioid overdoses, but the drug was removed from the U.S. market in 2008 due to low sales and is no longer available. Returning nalmefene to market in an easy-to-administer intranasal formulation may be an important addition to the nation’s preparedness for current and emerging opioid threats.”
2023,
Narcan isn’t the only version of naloxone, either. RiVive, a 3 mg naloxone nasal spray, was approved for OTC use in July 2023. Your pharmacist or healthcare provider can also supply you with other versions of naloxone, such as Zimhi injections and Kloxxado nasal spray.
The U.S. Food and Drug Administration approved Opvee, 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. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.
Opvee’s half-life is about 11 hours. Narcan’s half-life is about 2 hours. This means Opvee stays in the body longer — a potential advantage for reversing an overdose from synthetic opioids like fentanyl that can last a while in the body. Opvee and Narcan share similar side effects. But since Opvee stays in the body longer than Narcan, it has a higher chance of causing opioid withdrawal symptoms. Nausea, sweating, and fast heartbeat are a few examples.
Opvee is expected to hit the U.S. market by the end of 2023. But after it’s available, you’ll still need a prescription from your healthcare provider..
Narcan is already available for OTC purchase. It launched in the U.S. in early September 2023.
Bibliography
BioSpace. (2022). Opiant Pharmaceuticals announces positive topline results from head-to-head pharmacodynamic study comparing OPNT003, nasal nalmefene, to nasal naloxone.
