Global Health Ventures Inc. (OTCBB:GHLV), a specialty pharmaceutical company focused on sublingual (under the tongue) drug delivery, is pleased to announce that Regulatory bodies in the European Union (EMEA) have approved the use of our lead therapeutic drug, X-Excite in men similar to the erectile dysfunction drug currently on the market known as Viagra®.
"We are very pleased with the news of European approval and now plan to file with the FDA within next few months," said Dr. Hassan Salari, Global Health President & CEO.
EMEA approved Global Health to carry out a small (24 person) clinical trial side by side with the similar erectile dysfunction drug on the market known as Viagra®. This study, which is expected to start within next few weeks, will become the major milestone for X-Excite and will take approximately 3 to 4 months to complete. The study is designed to look at the speed each drug appears in the blood and its effect on liver enzymes that may address some of the side effects associated with the current route of administration.
X-Excite a sublingual formulation of sildenafil citrate. Sildenafil citrate is used to make one of Pfizer Incorporated's largest sellers Viagra®. It is scientifically known that sublingual delivery is the fastest way to get a drug into the blood and bypass the liver as first passage to the body. Many of the side effects of drugs are due to their liver metabolism and use of liver as first passage to the body. Global Health's sublingual delivery, which delivers the drug directly to the blood, should have fewer side effects, in theory then similar erectile dysfunction drug on the market known as Viagra®.
About Sublingual Technology
The Company's sublingual formulation is designed to enhance drugs to be delivered to the body without the need for injection. This design enables the vast majority of pharmaceutical drugs to be rapidly absorbed through the mucosal membrane (tissues of the mouth) quickly and efficiently. This technology works well for drugs that need faster results and have major side effects associated with gastrointestinal and/or liver break down. It is scientifically accepted that sublingual drug delivery route is the fastest and most efficient way of drug delivery after direct injection. The technology is tested against 40 major drugs and all can benefit from it...
About Global Health Ventures
Global Health Ventures is a specialty pharmaceutical company with expertise in drug delivery and formulation. The Company has a proprietary platform technology for drug delivery via the sublingual (under the tongue) route. This unique method delivers drugs to the bloodstream quickly with minimal drug breakdown in the liver or gastrointestinal system, a process that can greatly reduce side effects associated with the drugs. The Company's lead therapeutic product is a male sexual enhancement drug that is delivered via sublingual route and is called X-Excite. In experimental studies, X-Excite has been shown to reach the blood stream rapidly, producing maximal effect and having less of the unwanted side effects associated with oral delivery route. X-Excite is presently in clinical development in Europe. The Company's second drug "Relax-B" is also under development in Canada for anxiety. And, the third drug will be an anti-migraine drug. The Company plans to use the same technology to deliver a vast number of other FDA approved and non-approved drugs that require faster delivery, or reduced hepatic and gastrointestinal side effects. These include stress, sleeping disorders, pain killers, anti-allergy medications, heart and lung medication, migraine and addiction replacement therapies.