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Highlights
- PharmaTher resubmits information to FDA for ketamine approval by end of February 2025.
- FDA classification of deficiencies as minor brings Q2-2025 approval on the horizon.
- No new preclinical studies required as PharmaTher advances toward FDA approval.
PharmaTher Holdings Ltd. (CSE:PHRM), a specialty pharmaceutical company focused on developing ketamine for various medical applications, has announced that it is on track to resubmit key information to the U.S. Food and Drug Administration (FDA) by the end of February 2025. This resubmission follows the FDA’s Complete Response Letter (CRL) issued on October 22, 2024, which identified minor deficiencies in the company’s application for the approval of ketamine.
These deficiencies, which the FDA classified as minor, will be addressed in the resubmission. According to the FDA, the resubmission is considered a minor amendment, indicating that the company is not required to perform new preclinical or clinical studies. This is a positive development for PharmaTher, as it signifies that the application for approval is largely intact and that only specific updates and clarifications are needed to address the FDA’s concerns.
The FDA has specifically requested additional information regarding drug substance, drug product, manufacturing, and microbiology aspects. However, it is important to note that the FDA did not express any concerns regarding the stability of the ketamine submission batches, which have demonstrated 18 months of stability without issue. This stability is a crucial aspect of the approval process, as it confirms that the ketamine formulation is robust and reliable for medical use.
PharmaTher is committed to advancing its ketamine product and is confident in its potential to gain FDA approval. The company aims to resubmit the requested information by the end of February 2025, with the expectation that the FDA will set a new approval date, anticipated for Q2 2025. This timeline reflects the company’s dedication to bringing ketamine to market, a critical drug with significant medical applications.
Ketamine has long been known for its use in anesthesia and pain relief (analgesia), especially in hospital settings. However, beyond its FDA-approved indications, ketamine is increasingly used off-label in hospitals and clinics to treat a wide range of mental health, neurological, and pain disorders. The drug’s versatility and growing recognition as a treatment for conditions like depression, anxiety, PTSD, and chronic pain disorders make it a valuable asset in modern medicine.
For PharmaTher, the opportunity to expand the availability of ketamine beyond its current uses represents a significant step forward. The company envisions a future where ketamine can be used to address unmet medical needs across a variety of patient populations. Its mission to become a leading innovator and provider of ketamine aligns with the growing demand for effective treatments in areas where current options are limited.
The pending FDA approval of ketamine is a pivotal moment for PharmaTher, as it aims to leverage the drug’s potential to improve patient outcomes worldwide. With its innovative approach to drug development, PharmaTher is poised to play a key role in making ketamine more accessible to those in need. As the company moves toward resubmitting its application and anticipating FDA approval, its progress stands as a testament to its commitment to patient care and the development of novel therapeutic options.
