Amphastar Receives Complete Response Letter for Intranasal Opioid Overdose Med

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The regulatory agency rejected the medication, citing various issues related to device use.

FDA issued a complete response letter to Amphastar for its intranasal Naloxone (naloxone hydrochloride 2mg/0.5mL nasal spray) on Feb. 21, 2017, citing issues with device evaluation, user human factors study, and other factors that the company did not identify, Amphastar said in a press release.

Amphastar will still offer naloxone in pre-filled syringes for the treatment of opioid overdose. Amphastar's naloxone serves as a competitor to Kaléo Pharmaceuticals' Evzio, which has recently received some negative press because of a nearly 600% price increase. Amphastar has also gotten some heat for doubling the price of its own version in 2015. In June 2016, Senators Susan Collins (R-Maine), and Claire McCaskill (D-Missouri) wrote a letter to Amphastar’s CEO, asking the company to provide a justification for price hikes.

An intranasal version of the drug from Adapt Pharma is currently already on the market and goes by the trade name Narcan. Approved in 2015, it became commercially available in the early part of 2016.


Source: Amphastar