Ketamine pharmaceutical company PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) reported financial results for its third quarter ended February 28, 2022, and provided recent business highlights and updates. The company doesn’t have any revenue to report at this time but did note that it has nearly C$12 million in cash and investment. PharmaTher also reported that it is fully funded for its development programs, including ketamine injection and infusion product, ketamine microneedle patch and ketamine wearable pump device for mental health, neurological, and pain disorders.
“We have made great progress with our product and clinical development programs for ketamine as a novel treatment use for near-rare and rare disorders, while also creating unique product profiles including injectables/infusions, microneedle patch and a proposed wearable pump device where each will provide a unique solution to treat various mental health, neurological and pain disorders in hospitals, clinics and homes,” said Fabio Chianelli, Chief Executive Officer of PharmaTher. “We are focused on becoming a leader in advancing ketamine to treat unmet medical needs, and we are funded to complete our development programs for clinical studies and our expected submission for FDA approval of our ketamine injectable and infusion product for anesthesia and procedural sedation by the end of 2022.”
PharmaTher said it is seeking FDA approval for KETARX (ketamine injection and infusion product) for anesthesia and procedural sedation. It has also entered into a research collaboration agreement with Revive Therapeutics Ltd. (CSE: RVV) (OTCQB: RVVTF) for the development of a psilocybin microneedle patch. Plus, PharmaTher was granted a U.S. Patent No. 11,213,495 and Japanese Patent No. 6967532 for the combination formulation of FDA-approved ketamine and betaine anhydrous (KETABET), which has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.
In other promising news, the U.S. Food and Drug Administration (FDA) accepted an investigator-initiated investigational new drug application to proceed with a Phase 2 clinical trial evaluating ketamine in the treatment of Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease.