- PharmaTher has entered an agreement with the National Health Research Institutes of Taiwan to develop and commercialize a patented formulation of FDA-approved ketamine and betaine combination called KETABET.
- This new formulation is designed to treat mental health, neurological, and pain disorders.
PharmaTher (PHRM) has entered an agreement with the National Health Research Institutes of Taiwan to develop and commercialize a patented formulation of FDA-approved ketamine and betaine combination called KETABET. This new formulation is designed to treat mental health, neurological, and pain disorders.
This comes less than a month after PharmaTher agreed to sell their psilocybin program to Revive Therapeutics (RVV) to dedicate resources to their ketamine product pipeline.
Through clinical studies, KETABET has shown the potential to reduce the negative side-effects of ketamine, such as hallucinations, memory loss, confusion, and potential for abuse, while also enhancing the antidepressant effect.
KETABET utilizes a proprietary microneedle patch that allows patients to dose their medication without the supervision of a healthcare provider. The patch has the potential to introduce anti-tampering and anti-abuse features, similar to the tamper-resistant transdermal fentanyl patch.
KETABET consists of two main ingredients. The first ingredient, ketamine, received FDA approval in 1970 and is clinically used for analgesia, sedation and anesthetic induction. Recently it has been emerging as an alternative treatment option for depression. Clinical studies have shown that a low dosage of ketamine can produce an antidepressant effect for patients with major depressive disorder, bipolar depression, suicidal ideation, and PTSD.
The second ingredient in KETABET, betaine, was approved by the FDA in 1996 for the treatment of homocystinuria, a rare condition that interferes with an individual’s ability to break down protein from food. There is growing evidence that betaine plays a significant role in regulating brain functions and that it can have an antidepressant-like effect.
Preclinical studies have shown that the combination of ketamine and betaine produce a more robust antidepressant effect together than their individual effects, and that the combination blocked the psychotomimetic effects of ketamine.
PharmaTher is seeking FDA approval for a Phase II clinical study for KETABET. Many pharmaceutical companies are developing new antidepressants due to current approved medications having significant limitations, including unwanted side-effects, and delayed responses causing low remission rates among patients.
We believe KETABET has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions. We are pursuing the clinical development of KETABET to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine for FDA approval.”Fabio Chianelli – PharmaTher CEO
This is not the first ketamine antidepressant treatment that has received FDA approval. In March 2019, the FDA approved SPRAVATO, a ketamine nasal spray used along with oral antidepressants to treat adults with treatment-resistant-depression.
Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of a granted patent (Taiwan patent: I648049) and patent applications (International Publication Number: WO2017205666A1) titled, “Method and composition for decreasing the psychotomimetic side effect and addictive disorder of ketamine” in the U.S., Europe, Japan, Canada, Israel and China.