The FDA has approved Amphastar Pharmaceuticals’ NDA for 4 mg intranasal naloxone for the treatment of opioid overdose. According to the company, the nasal spray is delivered via a proprietary delivery device. A previous Amphastar NDA for a 2mg naloxone nasal spray received a CRL from the NDA in 2017, with the FDA asking for additional human factors and device evaluation studies.
Amphastar President and CEO Jack Zhang commented, “The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product. Utilizing our innovative device platform, the approval of naloxone hydrochloride nasal spray validates our technical capabilities as we can leverage this towards our intranasal pipeline.”
A reformulated version of Amphastar’s Primatene Mist epinephrine MDI for the treatment of mild asthma symptoms was approved by the FDA for over-the-counter sales in 2018.
Read the Amphastar Pharmaceuticals press release.
