Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.

Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model DFl to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.

Some observers believe Indivior is paying a very reasonable price to get hold of OPNT003, an intranasal formulation of the opioid antagonist nalmefene, which is expected to be filed with the US FDA by the end of the year.

Roche’s gantenerumab has failed to make the grade in its GRADUATE studies, leaving the field wide open for Eisai and Biogen’s lecanemab.