November 25, 2019 / 1:49 PM / 20 days ago

UPDATE 1-FDA declines to approve Adamis Pharma's Zimhi to treat opioid overdose

(Adds details on FDA decision, background)

Nov 25 (Reuters) - Adamis Pharmaceuticals Corp said on Monday the U.S. Food and Drug Administration declined to approve its opioid overdose treatment, raising questions around its chemistry, manufacturing and controls (CMC).

In a letter to the company, the FDA questioned the treatment's manufacturing process, but not its safety or effectiveness, Adamis said.

The drug Zimhi is a naloxone pre-filled single dose syringe used for emergency treatment of known or suspected opioid overdose.

The company plans to address the concerns raised by the agency by expanding tests around the drug's CMC. Adamis said the FDA response was received after markets closed on Friday.

The company said it will request a meeting with the FDA "as soon as reasonably possible" and plans to resubmit its application for approval.

Adamis has touted Zimhi, which delivers high doses of naloxone, a drug used for emergency treatment of known or suspected opioid overdose, as a part of the solution to the opioid crisis.

Opioids were involved in nearly 400,000 overdose deaths in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. (Reporting by Shivani Singh and Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

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