Alternative Delivery
by Isaac Wilson
June 2007
Developing novel mechanisms for drug delivery requires creativity and sound scientific platforms, but changing patient and physician behavior is often a greater challenge.
For the estimated 180 million people worldwide with diabetes, the development of an inhaled form of insulin to assist in managing the disease should have represented a major step forward. Even with the development of long-acting insulin and continuous delivery insulin pumps, insulin therapy as a whole has changed little since its introduction in 1921. And despite multiple attempts over the years to develop an alternative system to deliver insulin, none has made its way into clinical practice.
With its 2006 approval in both the United States and Europe, Pfizer’s Exubera offers patients with type 1 or type 2 diabetes an additional option for glycemic control. Still, patients and physicians often resist initiating a regimen of insulin therapy, and changing their behaviors and perceptions—particularly to embrace a novel delivery system—requires time, patience and education.
An Unmet Need
The enormous need for alternative insulin therapies was best demonstrated by the results of a 2003-2004 survey conducted by the American Association of Clinical Endocrinologists (AACE). In their study entitled The State of Diabetes in America, AACE surveyed more than 157,000 type 2 diabetics in the United States to determine the percentage of people who were not effectively managing their condition. The results showed 67 percent failed to meet the AACE’s current diabetes management goals. Although the survey failed to assess the reasons for this startling lack of disease management, it underscored the urgent need for manufacturers and clinical practitioners to develop new diabetes treatment strategies.
Dr. Priscilla Hollander, director of the Ruth Collins Diabetes Center at Baylor University Medical Center, in Dallas, Texas, USA, has been researching new treatments for diabetes for more than 20 years and was the principal investigator of a Phase III trial comparing Exubera to subcutaneous insulin therapy (Diabetes Care. 2004;27:2356-62). Since approximately 30 percent of type 2 diabetics require insulin to manage their diabetes, Hollander sees inhaled insulin as playing an important role in alleviating the burden of the disease. “Most patients are very interested in inhaling rather than injecting,” she says. “A lot of people really like [inhaled insulin] and find it perfectly acceptable.” Hollander says that although inhaled insulin can alleviate one of the largest patient barriers to insulin therapy—fear of injection—the larger obstacle is changing the behaviors of the practicing clinicians themselves.
In addition to the typically challenging task of educating physicians about a medication requiring a novel delivery system, Exubera is unique in that potential patients must undergo an additional level of screening to assess lung function. “The tricky thing about Exubera is that it requires a pulmonary function test, and most endocrinologists don’t have a spirometer in their office,” Hollander says. “It adds one more level of complexity for both patients and physicians.”
Physicians run into an additional barrier when they realize they have to prescribe the inhaled insulin in milligrams instead of units, Hollander says. “That’s just contrary to what most doctors are accustomed to.” As with any treatment decision, physicians must “look at individual patients, see what they need, see what’s going to work for them and determine how complex of a regimen they can handle.”
The lack of long-term safety data also is an area of concern to physicians in prescribing a newly approved medication. But Hollander says the preliminary results from a large, post-marketing study of Exubera will be presented in June 2007 at the American Diabetes Association’s Annual Scientific Sessions. Furthermore, Pfizer’s recently launched Web site listing all of its post-marketing commitments shows six ongoing post-marketing studies for Exubera as well as a pending pediatric study. Although the results will materialize slowly during the next several years, the resulting body of clinical evidence will lead to a better understanding of Exubera’s safety and efficacy profile.
Emphasis on Education
Since its U.S. introduction in the summer of 2006, Exubera’s sales have been relatively modest. Prescription sales data from Verispan show total revenues in the United States of just over US$4 million between July 2006 and April 2007; a number that Hollander attributes in part to the lack of an aggressive educational campaign from Pfizer. But that will change soon.
A spokesperson for Exubera says the drug manufacturer will launch both a direct-to-consumer advertising campaign, as well as a clinical and patient education program in mid-2007 using diabetes educators. The Pfizer Exubera Education Resource (PEER) will focus on educating primary care physicians on properly managing their diabetic patients and identifying patients who may benefit from inhaled insulin, as well as provide training to clinical staff and patients on how to prepare, use and maintain the inhaler.
Hollander is enthusiastic about Exubera’s place in clinical use. “It’s a major step because it’s a totally new and different way of delivering insulin, and it’s a very nice option to have available.” Looking ahead, though, she says inhaled insulin may have increasing importance as more emphasis is placed on initiating insulin therapy earlier in type 2 diabetics. “We’re starting treatment earlier, the treatments are getting more aggressive, the guidelines are getting tighter—it’s a very exciting time.”
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