Spain’s National Health System decided to fund the cost of Exubera insulin inhalers for diabetics.

Patients will pay no more than 3€ for the Pfizer inhaled insulin, and a new report says that pharmacies in Spain now have the drug in stock.

Those PR people have done it again: surveyed names of the brands that many of them work on, and rate which new products have the best names.

Pfizer’s Exubera inhaled insulin took 3rd place for the most ‘consumer-friendly’ new drug name.

Top honors went to Barr Pharmaceutical’s menopause drug Enjuvia. Eli Lilly and Co.’s Reconcile anti-anxiety medication for dogs took second place..

The survey is was done by the N.Y. branding and licensing company TippingSprung.

Pfizer, along with endocrinologists and researchers, presented the results of an Exubera safety study examining the effects of Exubera inhaled insulin on Type 1 diabetics for a little over 2 years. An abstract of the study can be seen below.

Here are a few important highlights and caveats regarding the study:

• It involved nearly 300 diabetics using Exubera inhaled insulin, and another group of almost 300 diabetics using injectable insulin.
• The study focused on Type 1 diabetics.
• Dr. Jay Skyler, one of the study’s authors, is a paid Pfizer consultant and occasional spokesman for Exubera. The ex-American Diabetes Association President appears in the drugmaker’s Exubera DTC advertising spots. Skyler is a consultant for Pfizer on Exubera and chaired the company’s Global Advisory Committee. He also gets paid by competing diabetes drugmakers to hawk their drugs.
• Skyler is a paid Scientific Advisor to a competing inhaled insulin developer, Mannkind Corp.

Pulmonary Safety Following Discontinuation and Readministration of Inhaled Human Insulin (Exubera[reg]) in Adults with Type 1 Diabetes

Authors:
PRISCILLA HOLLANDER, JAY SKYLER, LOIS JOVANOVIC, SOL KLIOZE, ALAN KRASNER, RICHARD RIESE, JOANN REIS, PAMELA SCHWARTZ, Dallas, TX, Miami, FL, Santa Barbara, CA, New London, CT

Results:

This interim analysis assessed pulmonary safety following discontinuation and readministration of Exubera[reg] (EXU; (insulin human [rDNA origin]) Inhalation Powder) therapy in adults with type 1 diabetes mellitus (T1DM).
T1DM patients (18-65 years) received EXU (n = 290) or subcutaneous insulin (SC) (n = 290) for up to 2 years in an ongoing, open-label study (comparative phase), followed by 6 months of SC insulin (follow-up phase) and a 6-month extension phase during which all patients received their original randomized therapy.

Small, nonprogressive treatment group differences in change from baseline forced expiratory volume in 1 second (FEV1) and carbon monoxide diffusing capacity (DLCO) occurred early during the comparative phase, and were not driven by outliers. These differences completely resolved upon discontinuation of EXU, and recurred to the same magnitude during the extension phase. Both treatment groups maintained glycemic control and hypoglycemic event rates were similar. Median insulin antibody levels increased in the EXU arm during the comparative phase (Month 24: 63.0 [micro]U/mL), decreased during the follow-up phase to near baseline levels (Month 6: 22.0 [micro]U/mL), and increased during the extension phase (Month 6: 42.0 [micro]U/mL); they remained stable on SC (Month 24: 4.4 [micro]U/mL; Follow-up Month 6: 4.4 [micro]U/mL; Extension Month 6: 3.6 [micro]U/mL).

In conclusion, FEV1 and DLCO changes observed during discontinuation and readministration of EXU therapy are consistent with a reversible, non-progressive and non-pathologic effect on lung function in adults with T1DM. EXU readministration is not associated with an augmented IAB response.[figure1][figure2]

Pfizer submitted its application to Health Canada, the Canadian government’s drug regulatory agency, in April of 2006, but still hasn’t received drug approval for the company’s inhaled insulin to be sold there.
That disclosure was made by Pfizer, Inc. (NYSE:PFE) in the company’s 2006 Financial Report.

This blog has been tracking Exubera approval in various countries around the world, including Canada.

Other countries in the far-flung corners of the world that have approved Exubera include Dubai and the United Arab Emirates.

We noted last summer the apparent condundrum in having Canadian pharmacies market Exubera online to American diabetics across the border when Health Canada “drug regulators haven’t even approved the new inhaled insulin.”

If a new post on Cafe Pharma is really from a Pfizer, Inc. (NYSE:PFE) drug detail rep, it could spell huge problems for the drugmaker’s Exubera sales.

A June 14, 2007 post suggests that one doctor that the diabetes drug rep spoke with had a patient on Exubera experiencing a signficant decrease in lung function:

“[She] los[t] over 100 points on her pulmonary function test Peak Flow. She has shortness of breath and can’t vacuum her house without resting now. She has been through CXR, PFTs, treadmill, VQ scan, and the doc can’t find anything other than her having been on Exubera to explain her newfound shortness of breath. The doc and patient are now struggling to find what else they can do to get this shortness of breath resolved — looking at steroids and other stuff now. Plus, he was bitching because Pfizer is sending him Adverse Event Reporting forms ad nauseum!” (emphasis added).

This anectdote of Exubera respiratory problems appears to confirm the fears that many physicians and diabetics have continued to express about Exubera: namely, that the inhaled insulin will not be a great way to treat diabetes if it creates pulmonary risks for patients using the diabetes medication.

In November, 2006, this blog reported on the results of a study by Tufts researcher Dr. Lisa Ceglia that raised important questions about the drug’s long-term safety. Dr. Ceglia’s primary reluctance to prescribe Exubera was that “for the time being, the most worrisome concern is the effect inhaled insulin may have on lung function.”

On February 1, 2007, this blog reported the results of an important study which concluded that the number of diabetics who would be ineligible candidates for Exubera should double in seven years. The study’s lead author, Prof. Timothy E. Davis of Australia, was also a member of another research team that first reported finding a link between Type 2 diabetes and reduced pulmonary function in 2004. Davis has been involved in the Fremantle Diabetes Study that tracks diabetic health over extended periods of time.

This blog previoulsy reported on allegations of quality control problems with Exubera that reportedly delayed brining the insulin inhaler to market. The reports included allegations that “[Pfizer] recall[ed] the inhalers because they aren’t working right,” and that there were “[p]roblem[s] with high quality control failure in the inhaler and issues with 1 mg blisters.”