Third time lucky as PharmaTher gets FDA approval for ketamine
This comes after two previous rejections in April 2024 and October 2024, each citing minor deficiencies in the abbreviated new drug applications (NDAs) for the therapy in anaesthesia, mental health, neurological indications, pain and sedation.
Ketarx's approval marks the first time the FDA has approved a ketamine product in an analgesic setting.
Following this decision, PharmaTher announced plans to explore Ketarx's potential in other indications through clinical trials focusing on 'mental health, as well as neurological and pain disorders', said the company's CEO and chair Fabio Chianelli, in a statement on 11 August.
Ketamine, the only psychedelic therapy to be named on the World Health Organization's (WHO) model list of essential medicines, has been prescribed off-label for a range of mental health, pain and neurological conditions by physicians in the US.
Ketamine has been included on the FDA drug shortage list since 2018, with the agency sharing concerns about the compounded version of the drug being used in the treatment of psychiatric disorders.
Jannsen Pharmaceuticals' Spravato (esketamine) is also a ketamine based product that first gained approval as a combination therapy with oral antidepressants in patients with treatment-resistant depression in 2019. Spravato has since received a label expansion for its use as a monotherapy in treatment-resistant depression in January 2025.
However, clinical research into ketamine outside of the anaesthetic setting has faced significant hurdles, primarily due to the lack of standardisation in treatment length, dosage and administration between trials.
Issues related to trial standardisation have resulted in the termination of nine Phase III and IV clinical trials within the last five years, including a study run by Qinghai University on the effects of esketamine on postpartum depression, according to GlobalData's Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
Ketamine's future potential in pharma
Following Ketarx's approval, PharmaTher will join Spravato on the market, with these being the only two ketamine-based drugs approved for use outside of anaesthesiology.
Forecasts suggest that Spravato reached blockbuster status in 2024. GlobalData analysts estimate the drug will make $1.4bn in 2025, with sales rising to $3.4bn in 2031.
With the value of ketamine-based therapies poised to grow significantly in the coming years, Ketarx could be set to thrive in this market, potentially replacing the use of opioids, which have high abuse potential.
There are other non-opioid-based pain therapies both in trials and on the market, including Vertex Pharmaceuticals' Journavx (suzetrigine), which gained approval in moderate-to-severe acute pain in January 2025.
"Third time lucky as PharmaTher gets FDA approval for ketamine" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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