The study demonstrated strong clinical and statistical significance that PreHistin, when administered before and during allergy season, clearly and noticeably resulted in fewer allergy symptoms compared with placebo.
Cobalis hopes these results will pave the way for an entirely new class of 100% non-sedating, anti-allergy medication with no common side-effects. PreHistin is a sublingual lozenge which will offer consumers a safer, more effective and less expensive alternative to existing over-the-counter (OTC) antihistamines and prescription allergy medications.
The strength of these results has served to foster a high degree of confidence in the company that equally strong positive results will be seen in a second planned study being conducted before FDA approval is sought for the treatment.
The company believes that the strong clinical results on efficacy, combined with over 50 years safe use of cyanocobalamin, the active ingredient in the patented PreHistin formula, should greatly facilitate the approval process by the FDA and other regulators. In written correspondence with Cobalis the FDA has said that “there are no safety concerns with the systemic exposure to cyanocobalamin.”