New Products

After steering through a controversy over soaring price of naloxone, FDA rejects Amphastar’s intranasal version

Amphastar CEO Dr. Jack Zhang

After coming under fire from angry lawmakers in the wake of its recent decision to more than double the price of its opioid intervention drug naloxone, Amphastar $AMPH says that the FDA has handed it a rejection for an intranasal version of the treatment.

The biotech didn’t spell out all the reasons for the rejection or go into much detail in its statement, but the company cited the agency’s questions about a “user human factors study, device evaluation, and other items.”

CRLs, though, aren’t public, so there’s no way to check on exactly what regulators are objecting to.

A pair of US senators, Susan Collins and Claire McCaskill, on the Special Committee on Aging, took Amphastar, Pfizer, Mylan, Adapt Pharma and Kaleo to task last summer for hiking the price of naloxone as opioid abuse ran rampant in the country. Amphastar raised its price of naloxone in early 2015 from $19 a dose to $41 and lawmakers have criticized the players in the field for a ten-fold increase in recent years, right alongside a national opioid addiction crisis.

Amphastar CEO Dr. Jack Zhang said:

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.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017