Waiting to Exhale - Part 2
Trials continue as new products press their way to market
NOTE: The inhalable insulin Exubera was discontinued in 2007. Read more here.
One year after making its debut, Exubera is still trying to find its footing in the insulin market. Before its FDA approval in January 2006, Pfizer, which manufactures Exubera, was the break-away leader in the race to develop an insulin that is not injected. Other companies whose inhalable and oral-insulin products still remain in the developmental stage include:
• Eli Lilly, which is partnering with Alkermes to develop AIR Inhaled Insulin System
• Novo Nordisk, which is developing the AERx iDM
• Generex Biotechnology, which has developed Oral-lyn, an oral insulin product now available in Ecuador but not the United States
AIR Inhaled Insulin System
In a telephone interview with dLife, Dr. Carlos Paya, vice president of Lilly Research Laboratories and leader of Lilly's pulmonary development platform, said Eli Lilly and partner Alkermes estimate that the AIR Inhaled Insulin System will be submitted for FDA approval at some point in 2009. Approval could come within 12 months of the submission. At present, Eli Lilly and Alkermes are in phase-3 trails for the AIR Inhaled Insulin System. According to data from phase-2 trials, Paya says the system, when compared against Humalog as a meal-time insulin, achieved similar blood glucose levels to that of Humalog. Paya adds that the Air Inhaled Insulin System will not be bulky and that research shows that patients want a slim, simple to use device.
"If we receive approval, patients will get a package that has a number of capsules," says Paya. "The capsules are filled with powdered insulin. The patient will take, depending on the units they need, the capsules with their fingers and insert them inside a device that has a cap. Upon closing the cap, the capsules get punctured. Then, you put the device into the mouth and take a deep breath.
Paya says that in phase 1 clinical studies, the AIR Inhaled Insulin System demonstrated an absorbability profile similar to that of other inhaled-insulin systems.
"About 10 percent of the insulin that is inhaled is absorbed," says Paya.
An Phan, director of product communications for Novo Nordisk Inc., tells dLife that Novo Nordisk's inhaled insulin project, AERx iDMS, is currently also in phase-3 clinical trials. In earlier clinical trials, the AERx iDMS system demonstrated itself well. According to January 2004 issue of Diabetes Care, in patients with type 2 diabetes, before-meal inhaled insulin via AERx iDMS was as effective as before-meal injected insulin in achieving blood-glucose control with similar tolerability.
"The phase-3 program is expected to include more than 2,000 patients with type 1 and type 2 diabetes, and will take place worldwide," says Phan. "Timelines related to its regulatory status and FDA review and approval milestones will be announced at a later date, when it's appropriate to do so."
Dr. Gerald Bernstein, vide president of medical affairs for Generex Biotechnolgy tells dLife that a conservative speculation on when Generex would approach the FDA for approval of Generex Oral-lyn would be later this year.
"This approach would place the U.S approval in approximately two years time," says Bernstein.
According to Bernstein, Generex Oral-lyn is a human regular insulin (like HumulinR) in a liquid formulation that creates bubbles, the size of which are too large to enter into the lungs. The bubbles penetrate the lining of the cheeks when blown into the mouth with an asthma-like spray. Once it is in the body, it is insulin.
"So it is no different than injected insulin once in the bloodstream, except that it is faster and has no tail of activity after two hours, minimizing the risk of hypoglycemia," says Bernstein.
In clinical trials, Bernstein says type 1s and type 2s have shown dramatic improvements in A1C when taking Generex Oral-lyn.
As for Generex Oral-lyn's clinical experience in Ecuador (it was approved there for use in May 2005), Bernstein says that, "So far, the letters and emails we receive have been positive and many are awaiting approvals in other countries throughout the world.
Bernstein says that dosing with Generex Oral-lyn is very precise, so you shouldn't see the absorbability problems evident with Exubera.
"Generex Oral-lyn is dosed just like injections," says Bernstein. "The flexibility of split dosage for meal-time application provides better control."
Upon approval, Bernstein says Generex is advising that Generex Oral-lyn be given with a basal insulin in type 1s, stating that Generex Oral-lyn's duration of action is two hours.
"In the case of type 2 patients, Generex Oral-lyn may be used as a meal-time insulin alone or with oral agents."
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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