PharmaTher Holdings Ltd. (OTC:PHRRF) continues on its path to becoming the leader in specialty ketamine products. A new product, developed in collaboration with the leader in design and manufacturing of wearable pen and auto injectors, CC Biotechnology Corporation, will combine PharmaTher's ketamine formulation with CCBIO's Felice Dose wearable delivery device. Clinical trials are expected to take place in the first months of 2023.
What The Innovation Implies For Ketamine Treatments
Ketamine, applied intravenously (IV) and intramuscularly (IM) for analgesia, sedation and anesthetic induction, is also emerging as a plausible option for treating various mental health, neurological and pain disorders, most notably Parkinson's disease.
As such, moving from IV and IM to wearable injection systems and microneedle patches could facilitate compliance and dose flexibility for both caregivers and patients. The new subcutaneous format might also improve safety and efficacy, reduce side effects, enhance patient comfort and adherence and reduce the time burden of treatment on patients and healthcare providers whether in hospital, clinic or at home.
"In addition, the current, evolving, and future therapeutic use of ketamine is dependent on the control of ketamine dosing to deliver pharmacokinetic profiles specific to each indication." said PharmaTher CEO Fabio Chianelli. "Therefore, our goal is to become a leader in specialty ketamine solutions, which include injectable, intravenous, microneedle patch and now a ketamine wearable device that each serve a unique solution to enable tailored pharmacokinetic profiles for various mental health, neurological, and pain disorders."
How It Would Work
CCBio's Felice Dose is a delivery motor system based on a body subcutaneous injector device that works for various drug volumes, concentrations and viscosities over variable and long-duration injections. It can deliver a stable dose of drug per unit time under discontinuous pressure, reducing the skin-swelling during injection and thus decreasing patient pain.
In addition, the system can adapt to the primary drug container, providing a very stable displacement unit for the drug, and the duration for filling and delivery can be programmed to suit the drug formulation.
In the present collaboration, CCBIO will be responsible for the development and clinical manufacturing activities and support PharmaTher's regulatory submissions towards the production and commercialization of the new wearable ketamine delivery device.