FDA Requests More Info on PharmaTher’s Ketamine Application

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher citing deficiencies in the company’s abbreviated new drug application for racemic ketamine (Ketarx), the company said. 

“The deficiencies cited in the CRL are classified as minor,” the company said in a statement. 

“The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested,” it added. 

PharmaTher said it will work with its third-party manufacturing partner to resolve these deficiencies and respond to the FDA in a timely fashion. The application had a goal action date of October 29, 2024.

The company previously announced plans to commercialize Ketarx for anesthesia, sedation, as well as pain, mental health, and neurologic disorders.

Ketamine is approved in the US for anesthesia and analgesia. Ketamine is not approved currently for treatment of any psychiatric disorder, but compounded ketamine products have been marketed for a variety of psychiatric disorders, including depression, anxiety, and posttraumatic stress disorder (PTSD). 

Since early 2018, ketamine has been on the FDA’s drug shortage list — which is believed to have fueled widespread availability and marketing of compounded ketamine to patients with psychiatric disorders.

In October 2023, the FDA issued an alert warning patients and healthcare providers about the potential risks associated with compounded ketamine products, including oral formulations, when used for psychiatric disorders.

The FDA is particularly concerned about compounded ketamine provided by telehealth providers for at-home use. 

In April 2023, FDA received an adverse event report of a patient who experienced respiratory depression after taking compounded oral ketamine outside of a healthcare setting for the treatment of PTSD. The patient’s ketamine blood level appeared to be twice the blood level typically obtained for anesthesia.

PharmaTher said it is “committed to its overall goal to solve the ketamine shortage problem in the US and to adhere to the FDA’s strict manufacturing guidelines and FDA-approved prescribing label.”