Inspiration And Expert Advice: Expert Columns

New Non-Injectable/Non-Inhalable Insulin Formulations in the Works

By Daniel Trecroci

With the recent discontinuation of Exubera® inhalable insulin, the future of insulin sort of came back to the present. The setback of inhalable insulin, however, has not stopped one company from pushing forward with its plan to develop insulin formulations that can be taken orally and rectally.

According to Israel-based Oramed Pharmaceuticals, Inc., Phase 1A clinical trials of its oral-insulin gel capsule were recently completed and passed with flying colors.

“Oramed has completed Phase 1A and is in the midst of Phase 1B of its clinical trials on healthy human volunteers,” Oramed told dLife. “The Phase 1A study evaluated safety and feasibility, while the Phase 1B study is designed to find the optimal dosage for the final formulation. Phase 1A results were very good and the company plans to announce the Phase 1B results shortly. Oramed will then move forward with commencing clinical trials on people diagnosed with diabetes.”

Phase 1A clinical trials included eight healthy volunteers who ingested Oramed’s patented oral insulin capsule. The Phase 1A trials examined changes in insulin, glucose and C-peptide plasma concentrations over time in healthy volunteers under several differing oral dosing scenarios. According to Oramed, “with the exception of the anticipated insulin-related hypoglycemic side effects, no significant adverse effects were noted after administration of Oramed's insulin gel capsule.”

The company's goal is for the completion of formal Phase 1 studies by the 3rd quarter of 2008.

An Insulin Suppository?

Indeed, Oramed is taking the bold step to examine the dynamics of taking insulin rectally. According to Oramed’s website (www.oramed.com), “this product will be particularly helpful for those whom an oral insulin capsule is not feasible such as small children.” Oramed told dLife that it will conduct phase 1 trials of its insulin suppository in South Africa to test safety and feasibility on healthy human volunteers. It adds that the rectal application of insulin is mainly designed for places where suppositories are more culturally acceptable than the United States.

“It can be extremely helpful for some one who has difficulty with the needles, such as older adults or small children,” says Oramed.

Learning its Lesson from Exubera®

In light of Exubera’s shortcomings experienced in the diabetes community, Oramed says that it has learned that people with diabetes are seeking an alternative means of insulin delivery, and that there is a need for oral insulin.

Additionally, Oramed has learned the importance of planning well for your product and the market that you are looking to sell to.

Oramed says it is trying to make these insulin products available as soon as possible, but it wants to guarantee that it is as safe and effective as possible.

“In order to do that, a lot of research and planning must be done and numerous milestones need to be met before the products can be available.”

For more information on Oramed Pharmaceuticals please visit their website at www.oramed.com.

Read more of Daniel Trecroci's columns.