BEVERLY HILLS, Calif., -- Eaton Scientific Systems, Ltd. ("Eaton Scientific" or the "Company"), a wholly owned subsidiary of Pristine Solutions, Inc. (OTCQB: PRTN) is pleased to announce select details of its planned multi-phase multi-location clinic trials for FDA approval of its novel drug indication Tropine 3, containing currently FDA approved Homatropine, in oral an suspension.
"We are currently finalizing preparations for what we believe will be the landmark clinical studies of our novel drug indication Tropine 3 for treatment and relief of the symptoms of hot flashes in menopausal women – one of the top concerns of women's healthcare today," stated Michael Borkowski, CEO and President of Eaton Scientific.
"The Company continues to build an outstanding team of very highly accredited medical professionals to plan, manage, and conduct every step of the clinic trials which were specifically designed to test, prove, and ultimately promote the short-term efficacy and safety Tropine 3. We anticipate that final Phase 1-2 protocol preparations and patient enrollment start dates will be confirmed shortly."
Eaton intends to conduct multiple clinical trials in Phase 1-2 & Phase 3 of Tropine 3. The first trial is planned to be an FDA protocol approved "Phase 1-2, Prospective, Randomized, Double Blind, Placebo-Controlled, Dose Escalation, Parallel-Group 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 Hormonal Replacement Therapy ("HRT")".
The drug, homatropine, is an anticholinergic medication that is an antagonist at muscarinic acetylcholine receptors and thus the parasympathetic nervous system. It is used in eye drops as a cycloplegic, and as a mydriatic in order to dilate the pupil. Homatropine is also given as an atropine substitute given to reverse the muscarinic and CNS effects associated with indirect cholinomimetic administration. Homatropine has been prescribed continuously and safely in the United States for over 40 years.
The Company anticipates conducting the clinic trials at multiple sites across the United States and plans to publish the results in medical journals and women's health publications. The Company intends to begin marketing Tropine 3 to pharmaceutical companies for potential acquisition following completion of the first Phase 1-2 clinic trial.
PR Newswire