PharmaTher on Track for Ketamine FDA Resubmission, Anticipates Q2 2025 Approval

Key Insights

• PharmaTher is set to resubmit its Ketamine New Drug Application to the FDA by the end of February 2025, addressing minor deficiencies outlined in the FDA's response letter.
• The FDA's feedback indicated that the resubmission will be treated as a minor amendment, focusing on drug substance, product manufacturing, and microbiology clarifications.
• PharmaTher anticipates a potential FDA approval for Ketamine in Q2 2025, marking a significant step in making the drug available for unmet medical needs.

PharmaTher Holdings Ltd. is progressing towards FDA approval for its ketamine product, with a resubmission of its New Drug Application slated for the end of February 2025. This action addresses the minor deficiencies identified in the complete response letter (CRL) issued by the FDA on October 22, 2024.

The FDA has indicated that the resubmission will be considered a minor amendment, as the identified deficiencies were classified as such. These deficiencies primarily concern the need for updated information and clarifications related to the drug substance, drug product, manufacturing processes, and microbiology. Importantly, the FDA did not raise concerns regarding the stability of the ketamine batches submitted, which have demonstrated 18 months of stability without any issues, and no new preclinical or clinical studies have been requested.

"We are very pleased with the responses by the FDA to the clarification questions in our post-CRL meeting request," said Fabio Chianelli, Chairman and CEO of PharmaTher. "The FDA has addressed our questions, paving the way for our Ketamine product’s new drug approval."

PharmaTher anticipates a potential FDA approval in Q2 2025. Ketamine is recognized as an essential medicine for anesthesia and analgesia, with increasing use as a sedative and painkiller in hospital settings. Beyond its approved indications, ketamine is also being utilized in hospitals and clinics for various mental health, neurological, and pain disorders.

Following the FDA's Complete Response Letter from October 22, 2024, which cited minor deficiencies, PharmaTher initially planned a post-complete response letter meeting for clarification. However, after receiving satisfactory preliminary responses from the FDA, the company canceled the meeting, deciding no further discussion was needed.

PharmaTher remains focused on its mission to be a leading innovator and provider of ketamine to treat unmet medical needs. The company is committed to keeping stakeholders informed and will continue to provide updates as they occur.