FDA Approves NRx’s Preservative-Free Generic Ketamine, but Its Bid to Ban Rivals’ Products Remains Pending

This morning, NRx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Abbreviated New Drug Application (ANDA) for its preservative-free ketamine product, which it has previously called KETAFREE[efn_note]Today’s press release does not reference this name, which may suggest that it will not be the approved brand name. We use KETAFREE in this article, as another name has not been shared by the company.[/efn_note].

KETAFREE is a generic product, hence the ANDA pathway, and is thus approved with the same label as Ketalar, the first ketamine product approved by FDA in 1970. Ketalar’s label describes its use in anaesthesia, and as such KETAFREE is, for now, only on-label for that purpose.

Speaking to Psychedelic Alpha, NRx CEO Jonathan Javitt confirmed that KETAFREE carries the Ketalar label. “The only difference is that it’s preservative-free,” he told us. In other words, it contains no benzethonium chloride (BZT), an antimicrobial preservative used in various medical products, including multidose vials of ketamine.

This time last year, we reported on NRx’s strategy to displace its generic ketamine competitors by:

1. bringing a preservative-free ketamine to market; and
2. petitioning FDA to remove BZT-containing ketamine products from the market.

Today’s approval completes the first step in that strategy. The second, a citizen petition asking FDA to pull BZT-containing ketamine products from the market, is still with the agency.

Separately, NRx is seeking to bring another preservative-free IV ketamine formulation on-label for depression and suicidality via a new drug application (NDA). That program is dubbed NRX-100, and the NDA would rely largely on existing data, including from NIH-run trials, data licensed from French health authorities, and real-world data collected in the U.S. via Osmind’s platform.

Below, drawing on an interview with Javitt and our reporting, we look at how KETAFREE reached approval, the case NRx has sought to mount against BZT, its claims to be “first” and “American-made”, the commercial picture and, briefly, NRx’s broader plans.