- Ketamine stock PharmaTher Holdings (CSE:PHRM) has received an amendment acknowledgement letter from the U.S. Food and Drug Administration (FDA) for its new drug application for ketamine
- The FDA has classified this as a minor amendment, meeting the criteria for priority review, and has set an approval goal date of June 4th, 2025
- PharmaTher completed the necessary tests and responses to address the FDA’s comments, resulting in the new approval goal date
- PharmaTher Holdings stock (CSE:PHRM) last traded at $0.19
Ketamine stock PharmaTher Holdings (CSE:PHRM) announced that it had received an amendment acknowledgement letter from the U.S. Food and Drug Administration (FDA) for its new drug application for ketamine. The FDA has classified this as a minor amendment, meeting the criteria for priority review, and has set an approval goal date of June 4th, 2025.
In a media statement, the specialty pharmaceutical company explained that this resubmission addresses the deficiencies outlined in the FDA’s complete response letter from October. The response requested new and updated information related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concerns about the stability of the Ketamine submission batches and did not request new preclinical or clinical studies. No additional deficiencies were mentioned in the letter.
PharmaTher completed the necessary tests and responses to address the FDA’s comments, resulting in the new approval goal date. The company wants to solve the Ketamine shortage problem in the United States and adhering to the FDA’s strict manufacturing guidelines. Ketamine has been on the FDA’s drug shortage list since February 2018, which has led to the widespread availability of compounded Ketamine products.
The FDA’s recent compounding risk alert highlighted potential risks associated with compounded Ketamine products for psychiatric disorders. With Ketamine’s removal from the FDA drug shortage list, the FDA is expected to restrict compound pharmacies from supplying it, creating an opportunity for PharmaTher to meet the demand in the U.S. market.
PharmaTher’s proactive approach and commitment to addressing the Ketamine shortage issue positions the company to play a crucial role in the pharmaceutical landscape, ensuring the availability of safe and effective Ketamine products.
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 $0.19 but has fallen 19.15 per cent since March 2024.
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(Top photo: PharmaTher Holdings Ltd.)