By: Daniel Trecroci
Generex Biotechnology announced that itsnoninjectable insulin formulation is nowavailable—in Ecuador at least.
Ecuador is the first country where anoninjectable version of insulin hasever been available. According to theInternational Diabetes Federation, there areapproximately 360,700 people with diabetesin Ecuador.
In a May 3, 2005, press release, GenerexBiotech said, “Generex believes that thisapproval will pave the way for additionaljurisdictional approvals around the world.”
Generex says it intends to start phase III trialsof Oral-lyn in Canada and Europe later thisyear.
Source: Generex Biotechnology
Gerald Bernstein, MD, FACP, is thevice president of medical affairs atGenerex Biotechnology.
How are the efforts going to get Oral-lynapproved in the United States, and what arethe obstacles?
I don’t see any real obstacles other than the naturalprocesses of the FDA. Although studies have beendone and will continue to be done in the UnitedStates, the formalities of moving to phase 3 here is astrategic one. The FDA has a file of Generex activities,which we keep current.
How is insulin spray different from inhaledinsulin?
Most important is not to confuse buccal delivery (viathe mouth) with pulmonary delivery (via the lungs).The former is visible and safe. The latter is invisibleand could be risky.
How is the dynamic of insulin spray different fromthat of injectable insulin?
When you inject insulin, it is deposited into the skin.It sits there and migrates to blood vessels. This givesfour- to six- or six- to eight-hour PK curves. Whenyou spray, it either crosses the buccal mucosa andrapidly enters the blood stream, or it is swallowedand destroyed. Thus, no tail. The duration of activityis about two hours with no tail, reducing risk forhypoglycemia.
What are some practical tips for people switchingfrom injectable to spray insulin?
As with all new products, dose adjustment isapproximated and then fine-tuned by experience.
Other Noninjectable Insulin in Hands of FDA
Pfizer, Inc., and the Sanofi-Aventis Group announced that the United States Food andDrug Administration (FDA) has accepted for filing a new drug application for the inhaled insulin Exubera.
Exubera is inhaled into the lungs prior to eating. Pfizer and Sanofi-Aventis are seeking approval to market Exubera for adult patients with type 1 andtype 2.
Exubera is currently also under review by the EuropeanMedicines Evaluation Agency.
Source: Pfizer, Inc.
March 2, 2005