The US Food and Drug Administration (FDA) has nixed approval of Zimhi, a high-dose naloxone injection product for the treatment of opioid overdose, according to a statement from the manufacturer, Adamis Pharmaceuticals.
In a complete response letter (CRL), the FDA said it cannot approve the new drug application for Zimhi in its present form and provided recommendations needed for resubmission, the company said.
The CRL did not raise any clinical safety or efficacy issues. The questions raised by the FDA relate generally to chemistry, manufacturing, and controls (CMC), Adamis said. The company plans to expand on the CMC testing that it has already provided to the FDA to satisfy the concerns outlined in the CRL.
"Obviously, we are very surprised and disappointed" by the FDA's decision, Adamis President and CEO Dennis J. Carlo, PhD, said in a statement.
"With a growing number of fatal overdoses as a result of more potent opioids like fentanyl, we believe there is an obvious need for higher dose forms of naloxone and we remain committed to bringing Zimhi to the market," he added.
"We believe the comments and recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain committed to this product and our mission to provide physicians and patients access to a higher dose of naloxone," said Carlo.
According to the US Centers for Disease Control and Prevention, more than 70,000 people died from drug overdoses in 2017, making it a leading cause of injury-related death in the United States. Of those deaths, almost 68% involved a prescription or illicit opioid.
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Cite this: FDA Rejects High-Dose Naloxone Shot for Opioid Overdose - Medscape - Nov 25, 2019.