Ken Valenti

	Diabetes treatment has seen sweeping changes in recent years, as more patients are diagnosed, and as the estimated cost to Americans-$245 billion in 2012-continues to rise. People with diabetes are diagnosed earlier, live longer, and have a wider range of treatments than even a few years ago.

	And pharmacists are playing a larger role in treating a disease that now affects more than 30 million people. Pharmacists help patients manage the disease and even advise potential diabetes patients on how to prevent it.

By 2012-the last time the American Diabetes Association (ADA) surveyed the expense of the disease-Americans were spending $176 billion in care associated with its treatment. The remaining $69 billion is ascribed to lost productivity. Medical costs include both direct and indirect impact, such as the way diabetes brings on or exacerbates other conditions.

	“If we see someone is in the hospital with the flu, they’ll stay in longer if they have diabetes,” said Matt Petersen, the ADA’s Managing Director of Medical Information.

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	Peterson is putting together the next five-year report on the cost of diabetes, due out next year. “I think we’ll inevitably see an increase,” he told 

	Diabetes is the seventh-leading cause of death in the United States, according to the CDC. Ranking diseases and conditions, however, is difficult because of overlap with other ailments, so the ADA does not try, Peterson said.

	The steady climb in costs is due to the sheer numbers of Americans developing diabetes. The difference in average health-care costs between those who have diabetes and those who don’t remains about the same, Peterson said. But the rate of diabetes has grown steadily over the past half-century or so.

	 The increasing monies spent on treating diabetes are not going to waste, Peterson said. “We’re getting what we’re paying for,” he said. “People with diabetes are doing much better than they were twenty or thirty years ago.” 

	In 1960, about 1% of the American population was diagnosed with diabetes, according to the CDC. By 2015, it was 7.4%-more than 23 million people. The ADA estimates that another 7.2 million Americans have undiagnosed diabetes, accounting for almost a quarter of the 30.3 million Americans with the disease.

	“We’re entering what I think is really an interesting new era for diabetes treatment,” said Robin Southwood, PharmD, CDC, BC-ADM, Clinical Associate Professor at the University of Georgia 

. “And we’re just at the beginning if it.”

	For example, a few years ago, there were two medications for diabetes. Now there are 11 or 12 types, Peterson said. These treatments take new approaches, including blocking the kidneys from reabsorbing sugar, so glucose is urinated out of the body. Two big advancements: Blood glucose levels are measured much more effectively, and diabetes can be diagnosed earlier.

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	Self-management has become a major component of treating and improving the lives of people with diabetes. Advising and educating patients is one area where pharmacists are playing a larger role, said Southwood. “There is a huge need for diabetes education,” he said. “Far too few people attend diabetes education sessions.”

	The role of the pharmacist in treating diabetes continues to grow. In some states, pharmacists can now order lab tests and refill prescriptions, said Mohamed Jalloh, PharmD, Assistant Professor in the Clinical Sciences Department at Touro University California 

. Pharmacists advise diabetes patients on lifestyle strategies such as regular exercise, he said.

	They can also educate people about diabetes in programs recognized by the CDC National Diabetes Prevention Program, which is aimed at heading off the disease before it starts. Jalloh said he also hoped to see more medications that prevent diabetes.

	“I do hope there’s a greater emphasis on prevention,” Jalloh said. “Prevention is more effective, and it’s safer than treating it.”

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The pharmacist's role in diabetes care will only continue to grow.

As Diabetes Numbers Rise, Costs Mount

	The FDA announced that it is denying Intellipharmaceutics approval on its drug Rexista. According to a 

 from the company making the drug, the FDA wants more information regarding its abuse-deterrant properties through nasal and oral routes. The FDA also had concerns with the blue dye used in the drug, and is requiring the company to provide additional information about it.

	The move comes after an FDA advisory commitee 

 in July against the drug's approval, 22 to 1.

	The agency also rejected the name Rexista for the drug, and is asking Intellipharmaceutics to submit alternate names for the drug, now simply referred to as Oxycodone ER. The company has one year to answer the FDA's requests.

	Taken as prescribed, Rexista Oxycodone XR acts like other pain-easing medications. But try to crush the tablets in order to snort the medication or dissolve them in liquid for injecting and the result will be a blue, sticky, viscous gel that is difficult to handle.

	The opioid analgesic, which the FDA is considering for approval, is like several others already on the market that have difficult-to-use properties if they are manipulated improperly. But the blue dye in the extended-release tablet is something new, said Isa Odidi, PhD, CEO and Co-Chief Scientist of 

, the Toronto-based company developing Rexista.

	“The purpose of the blue dye is to provide an early warning system,” Odidi said. “The moment you try to chew it, it creates this intense blue color in the mouth.”

	That, he said, creates “the ability to see quickly if someone is trying to abuse the product.”

Related article: How Should Opioid Addiction Be Treated?

	What’s more, alcohol does not change Rexista’s release of the drug, Intellipharmaceutics said. That prevents “dose dumping,” or using alcohol to amplify its effect. Odidi added that Rexista has an advantage over similar opioid products because it has been shown to have no “food effect,” and can be taken with or without meals.

	Rexista is intended for the continuous management of moderate to severe pain. If approved, it will join a growing list of opioid formulations aimed at curbing opioid abuse, an epidemic that kills 91 Americans each day, according for the CDC. The FDA encourages the development and advancement of abuse-deterrent opioids as part of its overall Opioid Action Plan.

	“The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that lack abuse-deterrent properties,” the agency says on its website. The FDA agency lists 10 opioids that are permitted to carry the “abuse deterrent” label.

	These drugs use various methods to curb abuse, such as additives that make the drugs unpleasant to chew or snort. With Rexista, the gel is formed by a polymer that activates when crushed and exposed to liquid or moisture.

Related article: Alternatives to Opioids

	Odidi said he hopes the blue coloration strategy will “introduce a new standard” to the industry. It can be especially effective in alerting people to first-time abusers or those who know little about opioids, he said.

	However, Stephen Hoag, PhD, Professor of Pharmacy Science at the University of Maryland School of Pharmacy, said serious drug addicts would not likely be hindered by the blue coloration. But he agreed that the presence of the dye could make it more difficult for casual users to abuse the drug without being noticed.

	“If a kid has blue all over his face, that would be very useful information for the parents,” he said.

	Michael Smith, PharmD, BCPS, Clinical Assistant Professor in the Department of Clinical Pharmacy at the University of Michigan College of Pharmacy, said the blue dye may have a limited effect.

	“I don’t know how effective it will end up being,” he said. “I think it will stop some people from abusing it, but it certainly won’t stop everybody.”

	Up next: Troubles ahead for the new drug

	Clinical trials showed that Rexista is essentially as effective as OxyContin by 

, Intellipharmaceutics reported in March, 2015. The drugs are similar enough that Intellipharmaceutics relied on data from the approval of OxyContin to speed up its approval application.

	Indeed, Purdue Pharma argues that the drugs are 

similar. In April, Purdue sued Intellipharmaceutics in U.S. District Court for the District of Delaware, claiming that the Canadian company infringed on six patents with Rexista, Intellipharmaceutics announced.

	While the FDA was expected to rule on the Rexista application by September 2017, the legal move stays the FDA from granting approval for 30 months, unless Intellipharmaceutics prevails in court or a settlement is reached.

Related article: How the FDA Will Combat Opioid Abuse

	Odidi described the lawsuit as part of the “normal course of business.”

	“We think it’s frivolous, we will fight it vigorously and we expect to prevail,” he said.

	A Purdue spokesman did not return a call from 

	Smith said the FDA is collecting information on the effect that abuse-deterrent drugs have on the number of people abusing opioids overall. He pointed to research suggesting that the introduction of abuse-deterrent OxyContin led abusers to migrate to other drugs, including heroin.

	The FDA requires drug companies “with product labels boasting abuse-deterrent properties … to conduct postmarket studies to determine the impact that [abuse-deterrent] technologies are having in practice,” the agency’s website says. “Having that information is critical, and will allow us to take the next important steps in this area.”

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Author | Ken Valenti

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As Diabetes Numbers Rise, Costs Mount

Abuse-Deterrent Opioid Rexista Makes Misusers Blue-Literally