Source: PharmaTher Inc.
  • PharmaTher (PHRM) has announced positive results from an observational study evaluating the impact of KETABET
  • KETABET aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression
  • Ten subjects were administered oral betaine anhydrous before ketamine treatment
  • The results of study demonstrated that pre-treatment with betaine prior to ketamine administration demonstrated a better recovery from ketamine effects and higher dose tolerability
  • PharmaTher is focused on the development and commercialization of specialty ketamine pharmaceuticals
  • PharmaTher Holdings Ltd. (PHRM) opened trading at C$0.16

PharmaTher (PHRM) has announced positive results from an observational study evaluating the impact of KETABET for subjects with depression.

KETABET aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.

The investigator-led observational study is a randomized crossover study with subjects suffering from unmanageable depression and currently receiving ketamine treatment but experiencing unwanted side effects of ketamine.

The study enrolled 10 subjects and aimed to determine if the administered oral betaine anhydrous before ketamine treatment can reduce the unwanted side effects observed in the first few hours of ketamine therapy.

Alleviation or reduction of side effects would support further progression of this product strategy. 

Dr. Raul Cruz, MD, Principal Investigator of the study, commented on the results.

“The results of this pilot observational study were very promising as the pre-treatment with betaine prior to ketamine administration demonstrated a better recovery from ketamine effects and higher dose tolerability for patients that typically experience dose limiting side effects. In general, patients that typically experienced nausea during treatment had a notable reduction and improved recovery. We are encouraged by the increase in alertness and decreased dizziness with pre-treatment of betaine and look forward to incorporating this combination into our practice for patients that require ketamine therapy for depression.”

Fabio Chianelli, CEO of PharmaTher, added,

“We are very pleased with the results from this study as it provides support for advancing our microneedle patch program in a potential Phase 2 clinical study evaluating KETABET™ for mental health and pain disorders.”

PharmaTher is preparing to engage the FDA to establish the next steps for a planned Phase 2 clinical study.

KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.

PharmaTher is a psychedelics biotech company focused on the research, development and commercialization of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. 

PharmaTher Holdings Ltd. (PHRM) opened trading at C$0.16.

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