
Amphastar Receives Complete Response Letter for Intranasal Opioid Overdose Med
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)
An intranasal version of the drug from
Source: Amphastar
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