Insulin in Pill Form?

Two pharmaceutical companies may be on their way to making it happen….

Many drugs available now have different formulations that make treating a condition and improving adherence among patients easier, but this is not the case with insulin, which is only available as an injection. However, possibly by the end of this decade or the beginning of next, insulin may be available in pill form. Currently, there are two pharmaceutical companies that are vying to produce the first orally available insulin product. Oramed Pharmaceuticals, Inc and Novo Nordisk are both seeking to be leaders and game-changers in what could be a multibillion dollar arena.

Oramed Pharmaceuticals Inc, based in Jerusalem, was established in 2006 after members of the company made what they call a medical breakthrough in technology that would allow for oral administration of insulin. The oral insulin capsule, ORMD-0801 has been successfully tested in various animal and human studies, and recently received FDA clearance to proceed with Phase II trials in the U.S. In addition to the oral insulin capsule, the company also has ORMD-0901, which is the oral form of the GLP-1 analog exenatide. After successful pre-clinical and Phase Ia results, Oramed is now conducting trials on healthy volunteers and type 2 diabetic patients for Phase Ib and Phase IIa trials, respectively. Since establishment, Oramed has received five patents for their technologies and has 34 additional pending patents.

Novo Nordisk has been a major player in diabetes care for 90 years. As the world’s largest seller of insulin products, it is no surprise that Novo Nordisk would be pursuing the possibility of producing insulin that is orally available. Currently, the company has several drugs of this type in the pipeline, all of which have Phase I status.

The initial concept or an oral insulin was first considered in the 1930’s, but could not be produced due to the breakdown by the digestive system. This is still a factor today; however, with new technologies that allow for better protective coatings and added ingredients, large amounts of oral insulin can be given to allow just enough to be absorbed and provide effective glycemic control, while the rest is destroyed.

Regardless of which company produces the first viable product of orally available insulin, the market will be huge. Patients who suffer from diabetes and require insulin may be more willing to begin insulin early in the disease and maintain adherence to therapy.

• Orally available insulin may be closure than most think.
• Oramed Pharmaceuticals and Novo Nordisk are in a race to produce the first orally available insulin pill.