- PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end of February 2025
- This resubmission addresses the minor deficiencies noted in the complete response letter issued by the FDA on October 22nd, 2024, marking a significant step towards obtaining FDA approval for ketamine
- The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. Importantly, the FDA did not express concerns about the stability of the ketamine submission batches
- PharmaTher Holdings stock (CSE:PHRM) last traded at $0.21
PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end of February 2025.
In a media statement, the specialty pharmaceutical company explained that this resubmission addresses the minor deficiencies noted in the complete response letter issued by the FDA on October 22nd, 2024, marking a significant step towards obtaining FDA approval for ketamine.
The FDA classified the deficiencies as minor, and the resubmission will be considered a minor amendment. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. Importantly, the FDA did not express concerns about the stability of the ketamine submission batches, which have demonstrated 18 months of stability without issues. No new preclinical or clinical studies were requested.
PharmaTher expects to receive a new approval date for Q2 2025. The company said its team will continue its mission to be an innovator and provider of ketamine to treat unmet medical needs.
Ketamine is used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. The drug has been classified as a Tier 3 drug shortage in Canada since February 2023. Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings.
PharmaTher Holdings Ltd. develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting delivery methods to enhance patient outcomes, such as KETARX to meet unmet medical needs for anesthesia, sedation, pain, mental health and neurological indications.
PharmaTher Holdings stock (CSE:PHRM) last traded at $0.21 and has risen 5 per cent since February 2024.
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(Top photo: PharmaTher Holdings Ltd.)
