Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version

Adapt Pharma has filed a marketing authorization application in Europe for its naloxone nasal spray for the treatment of opioid overdose, the company said. Adapt’s naloxone nasal spray, marketed as Narcan, has been approved in the US since 2015 and in Canada since 2016. The FDA also approved a lower dose of formulation of Narcan in January 2017.

Meanwhile, California-based Amphastar Pharmaceuticals, which already markets injectable naloxone, announced that it has received a complete response letter from the FDA regarding its NDA for a 2mg/0.5ml naloxone nasal spray, with the FDA citing the need for additional studies, including human factors and device evaluation.

Amphastar CEO Jack Zhang commented, “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.”

In December 2016, Amphastar announced that it had received a CRL for its Primatene Mist epinephrine inhaler, also in part based on the lack of a human factors study.

Read the Adapt Pharma press release.

Read the Amphastar press release.