PreHistin™ is intended to become the first-ever medication aimed specifically at rectifying imbalances in the immune system that trigger the over-production of allergy symptom-causing substances including histamines. By preventing or reducing the over-production of histamines before they are released, the need to block the symptom causing effects of histamine is eliminated, as is the need to rely on antihistamines.

Cobalis’ approach makes good marketing sense when compared to the current paradigm of blocking the action of already-produced symptom-causing substances with antihistamines or other drugs, which often results in debilitating and uncomfortable side-effects. PreHistin™, as a preventative approach to allergic disease, becomes The World’s First Pre-Histamine™.

PreHistin™ Product Profile

PreHistin™ is in a class of its own, literally creating an entirely new category of relief for seasonal and year-round allergy sufferers.

Clinical studies and research over the course of more than 15 years have demonstrated significant reductions in nasal symptoms, reductions in the use of other allergy medications, as well as reductions in the body’s imbalanced production of substances involved in the immune response. The active ingredient in PreHistin™ (cyanocobalamin) has been shown in clinical studies to cause none of the drowsy, sedating side-effects associated with many other allergy medications.

As a pleasant, cherry-tasting and easy-to-use sublingual lozenge, PreHistin™ provides a patient-friendly alternative to unwelcome injections as well as to powerful antihistamines that can often cause unwanted drowsiness and other uncomfortable effects. Cobalis has formulated the PreHistin™ lozenge to be dissolved under the tongue twice daily for 2-3 weeks prior to the beginning of the allergy season. Vitamin B 12 has an excellent and well documented safety profile. With no known negative drug interactions from its active ingredient, PreHistin™ may also be taken during the allergy season while continuing to take current allergy medications until PreHistin™ takes effect.

Cobalis conducted two sets of United States Food and Drug Administration (FDA) approved Phase III Clinical Trials in late 2004 and 2006 in preparation for approved consumer marketing of PreHistin™ for seasonal allergic rhinitis (hay fever). Results of the first of two required FDA Phase III Clinical Trials showed clear statistical significance that pre-seasonal treatment with PreHistin™ dramatically reduced allergy symptoms compared with placebo, whereas the second set of studies was inconclusive in the setting of a low pollen count at the time of the study. Follow-on studies are planned 1) to attempt to gain FDA approval as an OTC medication and 2) for the supplemental indications of pediatric doses, atopic allergic asthma as well as other outdoor, household, food and animal allergies, such as dust, mold, pet dander and peanuts. Presently, PreHistin is available and marketed as a “Cobalamin Supplement”.

Future planned Phase III research in the United States are planned and would be conducted as placebo-controlled, double-blind studies with confirmed seasonal allergy sufferers aimed at gaining FDA approval of PreHistin™, delivered by means of a sublingual lozenge with the indication of seasonal and perennial allergic rhinitis. These studies would be conducted at multiple sites throughout the United States by Board Certified in Allergists and Immunologists.

Cobalis is also planning to commence Phase II Clinical Trials to demonstrate the effectiveness of PreHistin™ in mitigating the symptoms of atopic migraine. It is estimated that nearly 40% of all migraine headaches are atopic in origin.

In addition to the sublingual lozenge, Cobalis is also planning to conduct testing of multiple delivery mechanisms such as a liposomal spray, quick dissolve tablets, drops and several other consumer-friendly approaches. Our goal is to offer a variety of methods so that each consumer will have their preferred mechanism for using PreHistin™.

Click here to read read more about PreHistin™ Phase III Clinical Trials (link to: PREHISTIN™ PHASE III CLINICAL TRIALS).

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