FDA Issues a CRL for Ketamine’s Abbreviated New Drug Application

Credit: US Food and Drug Administration

PharmaTher announced on April 18 the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Priority Original Abbreviated New Drug Application (ANDA) for ketamine (KETARX).¹

The letter was comparable to the FDA review letter PharmaTher received on February 12, 2024, stating quality deficiencies.

“Although we will not receive approval on the GDUFA goal date of April 29, 2024, we are pleased that the FDA review of our ANDA has been completed and no additional deficiencies were mentioned from its original review letter,” said CEO of PharmaTher Fabio Chinaelli, in a press release.

The abbreviated new drug application had intended to help increase access to ketamine, a drug used to treat pain, mental health, anesthesia, sedation, and neurological indications. Ketamine is essential for relieving pain. According to the WHO Essential Medicines List, it is used for anesthesia and analgesia.

Other than pain, Ketamine may help treat psychiatric disorders. A recent 2023 study found assessing the real-world effectiveness of ketamine intravenous therapy demonstrated significant improvement in depression, anxiety, and suicidal ideation.²

Ketamine has been in short supply since February 2018, according to the FDA’s list of scarce drugs.¹ A ketamine shortage also exists in Canada, classified as a Tier 3 drug shortage since February 2022.

This scarcity potentially prompted individuals to seek out compounded ketamine products. Although compounded ketamine products lack FDA approval for psychiatric disorders, these compounds are still used for mental health issues due to the shortage of the approved version.

However, compounded ketamine products can be dangerous for people using them for psychiatric disorders. On October 10, 2024, the FDA published a compounding risk alert stating the potential risks linked to compounded ketamine products for psychiatric disorders, particularly for telehealth providers that deliver in-home ketamine services.

“We have completed the necessary tests and are confirming to ensure our responses accurately reflect the FDA’s comments. We will submit them to address the CRL and obtain a revised GDUFA goal date,” Chinaelli said. “I believe that our goal to receive FDA approval for ketamine is closer.”

References

1. ^{PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine. PharmaTher. April 18, 2024. https://www.pharmather.com/news/pharmather-provides-update-of-its-priority-original-abbreviated-new-drug-application-for-ketamine6168232. Accessed April 29, 2024.}
2. ^{Hietamies TM, McInnes LA, Klise AJ, et al. The effects of ketamine on symptoms of depression and anxiety in real-world care settings: A retrospective controlled analysis. J Affect Disord. 2023;335:484-492. doi:10.1016/j.jad.2023.04.141}