Oral insulin available soon - in Equador
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Generex Biotechnology Corporation has put out a press release indicating they have obtained regulatory approval from the Ecuadorian Ministry of Public Health to sell their proprietary oral insulin spray formulation, called Oral-lyn. So people in Equador will soon be able to spray insulin into their mouths -- with no assurance of the safety of the product because no large-scale safety studies have yet been done.
Two small studies (on 44 patients) have been published showing that it works: Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study (this study had 23 patients), and Beneficial effects of addition of oral spray insulin (Oralin) on insulin secretion and metabolic control in subjects with type 2 diabetes mellitus suboptimally controlled on oral hypoglycemic agents (this study had 21 patients). Elsewhere on the Internet, it is stated that the Equadorian approval was based on the results of clinical trials involving more than 250 patients with diabetes.
But the large-scale, costly Phase III clinical trials required by responsible regulators in the US, Europe, and elsewhere have not yet begun. These studies will involve well over a thousand patients, and must include a sizeable number of patients with over at least a year's exposure to the product.
Why did Generex make this announcement now, before doing any large-scale safety studies? Looks simple to me: according to Generex's CEO, "This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales." It looks like they need more money to do the big studies. Money from Equadorians, apparently.
I must respectfully disagree with the CEO's next comment, that "This approval will also enhance our ability to procure additional similar jurisdictional approvals around the world." There's simply no way that the FDA or European or other major regulatory agencies will be rushed into approval of a novel route of insulin delivery simply because people in Equador have access to it. Indeed, the other regulatory agencies will scrutinize both the unstarted Phase III safety studies they always require, and the outcomes of people using the product in markets where the product is already approved.
So, although I suppose you could book your airline ticket to Equador to get insulin oral sprays soon, I'd suggest you wait until it's been documented to be safe -- in large studies, and on the good people of Equador.
Bill the diabetesdoc
Disclaimer: I previously worked in pharmacovigilance (drug safety) for sanofi-aventis, who together with Pfizer, is working on development of another alternative form of insulin administration.
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Thanks.
Generex Biotechnology Corporation has put out a press release indicating they have obtained regulatory approval from the Ecuadorian Ministry of Public Health to sell their proprietary oral insulin spray formulation, called Oral-lyn. So people in Equador will soon be able to spray insulin into their mouths -- with no assurance of the safety of the product because no large-scale safety studies have yet been done.
Two small studies (on 44 patients) have been published showing that it works: Oral spray insulin in treatment of type 2 diabetes: a comparison of efficacy of the oral spray insulin (Oralin) with subcutaneous (SC) insulin injection, a proof of concept study (this study had 23 patients), and Beneficial effects of addition of oral spray insulin (Oralin) on insulin secretion and metabolic control in subjects with type 2 diabetes mellitus suboptimally controlled on oral hypoglycemic agents (this study had 21 patients). Elsewhere on the Internet, it is stated that the Equadorian approval was based on the results of clinical trials involving more than 250 patients with diabetes.
But the large-scale, costly Phase III clinical trials required by responsible regulators in the US, Europe, and elsewhere have not yet begun. These studies will involve well over a thousand patients, and must include a sizeable number of patients with over at least a year's exposure to the product.
Why did Generex make this announcement now, before doing any large-scale safety studies? Looks simple to me: according to Generex's CEO, "This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales." It looks like they need more money to do the big studies. Money from Equadorians, apparently.
I must respectfully disagree with the CEO's next comment, that "This approval will also enhance our ability to procure additional similar jurisdictional approvals around the world." There's simply no way that the FDA or European or other major regulatory agencies will be rushed into approval of a novel route of insulin delivery simply because people in Equador have access to it. Indeed, the other regulatory agencies will scrutinize both the unstarted Phase III safety studies they always require, and the outcomes of people using the product in markets where the product is already approved.
So, although I suppose you could book your airline ticket to Equador to get insulin oral sprays soon, I'd suggest you wait until it's been documented to be safe -- in large studies, and on the good people of Equador.
Bill the diabetesdoc
Disclaimer: I previously worked in pharmacovigilance (drug safety) for sanofi-aventis, who together with Pfizer, is working on development of another alternative form of insulin administration.
Diabetes.Blog.Com is a blogcompanion to our main website, the Diabetes Monitor, which you can find at www.DiabetesMonitor.com
At the Diabetes Monitor today: We're continuing a series titled Physical Activity for Everyone. Today: why should I be active?
What is your impression of Oral-lyn so far? Have you had the time to review the data from the clinical studies?
What are your main concerns with the product? Complications or side effects, correct dosage, compliance. Could you please elaborate.
Do you think that it is likely that this a big breakthough or do you think that the product is a scam?
I understand that the product is now for sale in Ecuador, but I have had difficulty finding more information about the product.
I would love to see a greater discussion about Oral-lyn. Thank you!
(Comment this)
I would like to ask that if I can order some Oral lyn online for my father who lives in Turkey . I am in germany and I dont know how to order some packages.
Please give me some information about how I can order it
Thanks
Mehmet
(Comment this)
Thanks for your feedback on thediabetesblog.com.
I know the oral insulin press release announced the product only being available in Ecuador. It's a step in the right direction, for patient compliance sake. Hopefully we can see more resounding results and more concrete data supporting the concept. I was told by Generex that they were going to begin clinically testing it in the US in the future. No date, as of yet :(
Thanks for the feedback!
Best,
Allie Beatty (Comment this)