The U.S. Food and Drug Administration has approved KETARx for use in surgical pain management. The manufacturer, PharmaTher, indicated there are plans to continue developing ketamine for potential use in mental health, neurological, and pain disorders. Ketamine is the only psychedelic or psychedelic-adjacent drug on the World Health Organization’s Model List of Essential Medicines.
The global ketamine market, currently valued at $750 million, is projected to reach $3.42 billion by 2034, with a compound annual growth rate of 16.4%. Esketamine (SPRAVATO®), an FDA-approved treatmnt for depression, has an annualized sales run rate of $1.6 billion, with projections of $3 billion to $3.5 billion by 2027 to 2028. PharmaTher’s development pipeline includes potential applications for depression, Parkinson’s disease, amyotrophic lateral sclerosis, and chronic pain syndromes such as complex regional pain syndrome.
In October 2023, the FDA issued a risk alert regarding compounded ketamine products used for psychiatric disorders, citing safety considerations. Robert F. Kennedy Jr., Secretary of Health and Human Services, has supported expanding research and legal access to psychedelic therapies for veterans.
The Veterans Health Administration funds ketamine infusions for retired military personnel with depression, post-traumatic stress disorder, and chronic pain. The FDA’s Commissioner’s National Priority Voucher program is intended to expedite access to safe and effective treatments, which could facilitate future regulatory pathways for ketamine.
Source: PharmaTher
