PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

Successfully delivered ketamine and KETABET (ketamine and betaine) via microneedle patch, unlocking the potential for desired dosage forms and pharmacokinetic profiles

Pursuing Phase 2 clinical studies in treatment-resistant depression and pain indications in Q4-2022

TORONTO, June 29, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that it has successfully completed its research study evaluating the Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH, to deliver ketamine and KETABET (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, neurological disorders, and chronic pain.

PHARMAPATCH has been shown to successfully deliver esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Research results were published in a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”¹.

The aim of the research program led by Prof Ryan Donnelly at Queens University Belfast (“QUB”) was to develop and characterize PHARMAPATCH for the transdermal delivery of ketamine and KETABET in a sustained manner and finalize production scale-up processes for clinical studies. Characterization of drug recovery and stability before drug permeation from films via hydrogel-forming microneedle array patches (“MAP”) was assessed in vitro using the Franz cell apparatus. Based on the findings from in vitro permeation investigations, lead candidate MAP formulations were selected and brought forward for in vivo testing using Sprague-Dawley rats to assess the ability to achieve sustained plasma concentrations of ketamine and betaine within the therapeutic range for potential antidepressant therapy over the course of 48 hours.

PHARMAPATCH is an alternative platform that allows ketamine to be delivered transdermally in a sustained and de-risked manner. The results from this study represent the first time that multiple formulations of PHARMAPATCH for the delivery of ketamine and betaine have been developed, characterized and tested in an animal model. Extensive characterisation of each drug-containing polymeric film and hydrogel-forming MAP combination in terms of swelling capacity, insertion capabilities, drug recovery, stability, and ultimately in vitro drug permeation using the Franz cell apparatus allowed the selection of the most promising candidate formulations for in vivo testing. Hydrogel-forming MAP-mediated delivery of ketamine and betaine were compared with intramuscular injection and orally administered solution, respectively. At regular time intervals during the 48-hour rat study, blood sample results demonstrated that PHARMAPATCH was able to deliver plasma levels of ketamine (between 70-200 ng/mL) in a controlled manner throughout the study.