The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Zimhi™, an investigational high-dose naloxone injection product for the treatment of opioid overdose.
Naloxone, an opioid antagonist, is used for the emergency treatment of known or suspected opioid overdose. Currently, naloxone is supplied in ampules and vials for IV, IM or SC administration, in a prefilled auto-injector, and as a nasal spray.
In November 2020, the FDA issued a second Complete Response Letter (CRL) to Adamis Pharmaceuticals regarding the NDA for Zimhi stating that the application could not be approved in its present form due to issues pertaining to Chemistry, Manufacturing and Controls. To address these issues, the Company has provided the FDA with additional analysis and information.
A Prescription Drug User Fee Act (PDUFA) target date of November 12, 2021 has been set for the application.
“We are pleased with the FDA’s decision to accept for review our NDA for Zimhi. I believe this underscores the need for additional treatment alternatives for narcotic overdose,” said Dr Dennis J. Carlo, President and CEO of Adamis Pharmaceuticals. “We look forward to working collaboratively with the FDA during the review process to support the case for approval of Zimhi.”
The FDA recently approved Kloxxado™ (naloxone hydrochloride), a higher dose naloxone nasal spray, for the emergency treatment of known or suspected opioid overdose.
Adamis Provides Update on Zimhi™. [press release]. San Diego, CA: Adamis Pharmaceuticals Corp; June 9, 2021.