Amphastar Naloxone Intranasal Approval

In a disappointing press release issued February 21, 2017, pharmaceutical company Amphastar announced that its New Drug Application for Intranasal Naloxone received a Complete Response Letter from the U.S. Food and Drug Administration “FDA”.

In particular, the FDA listed human factors engineering issues and device safety and issues that prevented drug approval. In response to the FDA letter, Amphastar expressed disappointment, but highlighted the number of opioid overdoses in America and expressed confidence that it would be able to resolve the issues identified by the FDA.

The new drug, formally Naloxone Hydrochloride 2mg/0.5mL Nasal Spray is designed to rapidly treat emergency opioid overdoses that present symptoms consistent with respiratory and central nervous system depression.

“While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible,” said Amphastar CEO Jack Zhang.

In the mean time, while the company waits for FDA approval, the inhalation version of Amphastar’s opioid antidote will continue to be available in pre-filled syringes.

 

Read Full Press Release

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