Eaton Scientific Systems, Ltd. (“Eaton” or the “Company”) a wholly-owned subsidiary of Pristine Solutions, Inc. (OTCQB: PRTN) is pleased to announce that it has completed the Protocol for the Clinical Trial for Tropine 3, its novel indication of homatropine, in oral suspension to be prescribed to women afflicted with hot flashes during pre-menopause, peri-menopause, and post-menopause.
Eaton CEO, Michael Borkowski, announced today that Eaton has a complete Protocol that is the guideline for Eaton’s Clinical Trial. “This is a very important step in the process of seeking FDA Approval for Tropine 3 and illustrates our progress towards the Clinical Trial.”
The Protocol and proposed Clinical Trial will be a Phase I/II, Prospective, Randomized, Double Blind, Placebo-Controlled, Dose Escalation, Open Label Study to Test the Efficacy and Safety of Homatropine Methylbromide Oral Suspension on Selected Climacteric Symptoms and Quality of Life in Menopausal Women Not Receiving HRT.
Homatropine methylbromide has been used as a drug in humans for over 50 years. Currently, it is used to discourage overdose in the popular narcotic cough syrup Hycodan.
Due to the long established use of homatropine methylbromide, the usual bench toxicity and animal studies will not be performed for this IND application. Instead, a combined phase I/II design will be used. This design incorporates both dose-finding rules and early stopping rules in terms of response and toxicity, thus combining elements of more typical Phase I and Phase II designs.