Drug Topics - October 13, 2008 - (Page 4s)

4s DRUG TOPICS Oct. 13, 2008 www.drugtopics.com tions. In the United States, diabetes is usually treated by primary care physicians who are more familiar with drugs than delivery. “Next to pumps, the most accurate and economic delivery route we have is the insulin pen,” Meece said. “Pharmacists know that, endocrinologists know that. Primary care docs are just starting to see that message.” Cost is another key factor. Payors outside the United States have long covered pens because they are more cost-effective than syringe and vial delivery. S's: sports, shower, swimming, shopping, sleeping, sex, and sauna. In Britain, Starbridge Systems is refining a two-part system connected by wire. A disposable patch contains drug reservoir, pump, and cannula. A separate unit with power and control circuitry plugs into the patch and also adheres to the skin. “The mouth is a marvelous self-healing area.” Inhaled insulin products Pumps and patches Dr. Buse said insulin pumps are another hot delivery technology. Once the insulin delivery schedule is set, administration is precise, and no drug is wasted. The ultimate goal of pump delivery is closed-loop glucose monitoring/sensing and insulin delivery. A 24/7 closed-loop system is still years in the future, he said, but patients can expect automated overnight monitoring and delivery in the very near future. For now, Dr. Buse said, size remains the most important factor. Smaller is better. One of the smallest is a patch pump called OmniPod. Pump, reservoir, and cannula sit on an adhesive patch (1.6 inches by 2.4 inches by 0.7 inches) stuck to the skin. A wireless PDAsized control unit is carried in pocket or purse. “The companies that don’t have patch pumps are working on them,” he added. Downsizing is the next step. In Israel, Medingo Medical Solutions is developing Solo, a two-part pump smaller than OmniPod. Medingo claims that the patch, which contains the insulin reservoir and cannula, is safe for what it calls the Seven Exubera was the biggest flop the diabetes world has seen recently. Introduced in 2006, it was withdrawn by Pfizer in 2007 because of poor sales. Novo Nordisk and Lilly quickly dropped their inSpray delivery products haled insulin projects. What Bucal delivery is already in North had been a crowded field has America — but not in the United been reduced to a single comStates. Toronto-based pany, California-based Generex Biotechnologies MannKind. “If you markets an oral spray inlook at Exubera and sulin called Oral-Lyn in the products [that] Ecuador and India. “Buthere would have been cal delivery is extraorfrom Novo and Lilly, dinarily simple,” Gerald the only dif ference Bernstein, MD, Generex was pulmonar y device president of mediliver y,” Ma nnK ind cal affairs, said. “For the Gerald Bernstein president Haken EdMD, Generex VP patient, it is not at all strom said. “They were intimidating.” all commonplace insuAdministration is by metered lin at a significant price premium. spray into the mouth, through We have a different mechanism of what looks like an asthma inhaler. action, different pharmacokinetInsulin reaches the bloodstream ics, different pharmacodynamics.” within five minutes, peaks in 15 MannKind’s product, Technominutes, and disappears within sphere insulin, is a rapid-acting two hours. Droplets are too large monomer insulin loaded onto pHto be inhaled, even if the user sensitive organic molecules. The tries, Bernstein said. “It is the per- insulin is dried to a powder, packed fect meal insulin because of that into plastic cartridges, loaded into onset,” he said. “There is no insu- a palm-sized inhaler, and inhaled lin tail like there is with injected before eating. Carrier particles formulations, so the probability of dissolve on contact with the pHhypoglycemia is almost nil.” neutral lung surface, allowing the Generex uses a combination insulin monomers to diffuse into of surfactants that allow insulin the blood. Peak insulin levels appear to quickly penetrate the bucal in 12 to 14 minutes. About 80 percent of mucosa, primarily through the Technosphere insulin disappears within inner cheek walls. Surfactants three hours, he said. That compares also enhance the solubility and to 30 percent of injected rapidstability of the drug, Bernstein acting insulin. “When you inject said. Phase III trials are already insulin, you have to snack to use up under way in the United States, the remaining insulin. You’re with initial results expected in feeding your injection. We have June 2009. A new drug applica- an insulin that more closely tion (NDA) could be submitted mimics a healthy individual. by the end of 2009. “We’ve That’s why we see less weight never seen negative events with gain a nd e ven wei g ht l o s s Oral-Lyn,” Dr. Bernstein said. w it h s om e p at ient s .” http://www.drugtopics.com

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Drug Topics - October 13, 2008 Contents Latebreakers Letters Kansas Pharmacists Partner with Law Enforcement to Fight Meth Use Pharmacy Board to Oversee Med Distribution at West Virginia Free Clinics Rx Care JP�at Large Celebrating Community Special Report Self-Care Government and Law Newer Treatment Option for Type 2 Diabetes New Products Advertisers Index Technology Classified Viewpoint:�Pharmacists Must Change our Ways

Drug Topics - October 13, 2008

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