PharmaTher Applies For Pre-IND Meeting With US FDA For Ketabet
PharmaTher Holdings (CSE: PHRM) this morning announced that it continues to push forward with the development of Ketabet. The company has now formally applied for a pre-investigation new drug meeting with the US FDA for the development of the product.
With the filing of the pre-IND, the company has also applied to conduct a proposed phase two clinical study, which will examine Ketabet as a potential treatment for depression, alone and in combination with the firms microneedle technology. The proposed meeting will look to also focus on a drug development plan that will see Ketabet administered via this tech developed by the company, while the firm also looks for approval for Fast Track designation for treatment in patients with major depressive disorder.
The hydrogel-forming microneedle patch has been developed to provide a novel method of delivery for ketamine and other psychedelics while improving safety, efficacy, and compliance when compared to other methods of administration.
“We have an insatiable focus on developing and commercializing novel uses, formulations and delivery forms of ketamine. We are committed to solving the ketamine puzzle and unlocking its true potential to treat depression by leveraging our robust intellectual property portfolio, clinical and regulatory experience [..] We are now in a position to lead the way in reviving ketamine and KETABET™ as a potential FDA-approved prescription-based therapy for mental health, neurological and pain disorders.”Fabio Chianelli, Chief Executive Officer of PharmaTher
PharmaTher Holdings last traded at $0.76 on the CSE.
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