Hello everyone, see what you think about this:
The generex biotechnology corporation presented an innovative system for insulin administration through the mucosa of the mouth and the FDA has granted approval for the use of Oral-Lyn ™ treatment in the treatment of FDA insideof the IND program that corresponds to the acronym in English of new research drugs (research New Drug).
The FDA IND treatment program allows companies to provide access to drugs that are in the research phase to certain patients suffering from very serious diseases and who have their life in danger and for which there is no satisfactory alternative treatment.The drugs granted by the FDA approval, for the IND treatment program, must demonstrate the perspective of effectiveness by clinical tests.
In accordance with a structured treatment protocol, Generex will provide ORAL-LYN ™ to diabetes with very serious problems and who have their life in danger, which are not eligible to participate in phase III of the clinical trial that worldwidecarrying end generex.
To learn more about the availability of Oral-Lyn ™ generation according to the IND treatment program, according to FDA requirements, the company will provide information within clinicaltrials.The details will include the study design and participating sites and/or doctors.Oral-Lyn ™ will be available only to be delivered by the doctors who are registered in the FDA treatment program, so in Spain you can not access it yet.
Oral-Lyn ™ continues in phase III with about 350 patients in about 75 sites throughout the world, including the US and Canada.The company prepares to collect all the information and deliver a new request to both FDA and other public health organizations of the main ones in key markets.The drug is currently being distributed in countries such as Ecuador, Algeria and Lebanon.
Broadly speaking, Oral Lyn is an oral insulin, whose pharmaceutical shape is an applicator very similar to that used by patients suffering from asthma.The mucosa of the oral cavity is absorbed.It is regular human insulin.It has an absorption that starts between 3 /5 minutes after being applied, with a maximum action peak between 50 and 60 minutes of its application.Its duration in the human organism does not reach 2 hours and has low hypoglycemic power.
