FDA rejects Amphastar’s application for NDA for intranasal overdose treatment

pharmafile | February 21, 2017 | News story | Research and Development Amphastar, FDA 

Amphastar has received a Complete Response Letter (CRL) for its New Drug Application (NDA) for an intranasal version of Naloxone, with the FDA rejecting the new method of application. Amphastar announced in a statement that it had rejected the NDA because of issues with “human factors study, device evaluation, and other items that need to be addressed”.

The points of contention are not particularly clear, as this is the only details that Amphastar released from its rejection. The NDA relates to a 2mg/0.5mL Nasal Spray, Intranasal Naloxone – a new formulation that would complement the existing in the delivery via intravenous, intramuscular or subcutaneous use.

The latter indications have caused a certain amount of controversy in regards to pricing. Amphastar increase the price of 10 pre-filled syringes from $120 to $330 in October 2014 – a decision that caused an immediate backlash from a range of political figures, notably Bernie Sanders.

The major issue with the price increase, not simply because naloxone is an old drug, but also because the use of the drug is in those who are overdosing on opioids. Transparently profiteering on those people who are most vulnerable and in need of help did not go down particularly well and Amphastar was forced to reach price reductions on a state-wide level.

Amphastar’s CEO, Dr. Jack Zhang, commented in the statement: “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.”

Ben Hargreaves

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