Toronto (National Post/Cdn Diabetes Assn) – Rebecca Killion gives herself several insulin shots a day, a regimen she has followed for 16 years, to help control her blood sugar. It’s been tough, and still her glucose fluctuates a lot. So she is thinking about beginning a new drug — an inhaled insulin that would mean fewer of the needles she loathes. She hopes it comes with the bonus of better managing her diabetes, reducing risk of damage to her kidneys, eyes and other organs.
The 57-year-old Bowie, Md., woman heard about Afrezza while it was in clinical trials. Intrigued, she became the patient representative on the Food and Drug Administration panel that provided the feedback leading to the drug’s approval and then its commercial release in February.
Killion and other panel members reviewed reports from the drug’s manufacturer, MannKind, studied clinical trials and read through the FDA’s own reports. They determined, she said, that Afrezza had potential as an effective way to control glucose with fewer injections.
Some diabetes doctors are cautiously optimistic that this type of insulin could make life easier for patients who are averse to needles and possibly yield better outcomes. Diabetics inhale a dose before each meal to avoid glucose spikes after eating.
People with Type 1 diabetes — the less prevalent form, in which the body does not produce insulin — still need a daily injection to provide long-lasting insulin.
Type 2 diabetics — whose bodies don’t make enough insulin or are resistant to it — can use the inhaled version along with pills, though doctors say some may need a daily injection.
Some clinicians are skeptical. They feel it’s too early to know if the drug has therapeutic benefits. Its long-term safety and efficacy are still under investigation. The package carries an FDA label warning of health risks for people with chronic lung disease. It advises that Afrezza is not recommended for people who smoke or recently stopped smoking or for children.
Afrezza comes in premeasured cartridges that patients insert into a small device. They close it and inhale on its tip.
Killion was 38 when she was diagnosed with Type 2 diabetes, and although that wasn’t the best health news, at least her doctor thought her illness could be managed with pills.
Three years later, she lapsed into a diabetic coma.
“I woke up after a few days and heard I had Type 1 diabetes and needed injections every day for the rest of my life,” she said.
She tried an earlier form of inhaled insulin, Exubera, which was taken off the market in 2007 after a year and a half because of inadequate sales. Killion found the device was awkwardly large and not user-friendly.
“It was like a bong,” said Killion, adding that dosing units were different from liquid insulin, so patients had to figure out conversions, unlike with the new drug.
About 29 million Americans, more than 8 million of them undiagnosed, have diabetes, according to the Centers for Disease Control and Prevention. Some may have no symptoms for years, says Robert Ratner, chief scientific and medical officer for the American Diabetes Association, based in Alexandria.
Some people inject themselves three or more times a day, sometimes for 50 or 60 years, tempting them to stop the grueling routine, and interrupting treatment can be dangerous.
“People take an insulin holiday because it’s hard to do that often and long,” Ratner said. “And there are negative social perceptions that deter insulin usage.”
Many diabetics, he said, are not comfortable taking out a syringe and injecting themselves in public — in the lavatory of a restaurant, for example, before having a meal.
“We don’t know if Afrezza will do better, but a lot of lessons were learned from Exubera,” Ratner said, “and this is a better product.”
Killion has gotten her share of suspicious looks when she takes out her insulin vial and needle case in public or at work. “I was in a conference,” she said, recalling one experience, “and a woman yelled from across the table, ‘What are you doing?’ ”
Studies report that Afrezza reaches peak levels in 12 to 15 minutes, vs. an hour with injected insulin. And the body returns to pre-meal insulin levels quicker.
“This means Afrezza matches [natural body] dynamics of food intake and absorption well,” said Janet McGill, an investigator on Afrezza trials at the Washington University School of Medicine in St. Louis.
The most common adverse reactions are cough, throat irritation and hypoglycemia (low blood sugar); people with chronic lung problems may experience wheezing and constriction of air passages in the lungs.
The FDA is requiring further study to evaluate safety and efficacy in children. And Afrezza will be evaluated for cardiovascular risk and its long-term effect on pulmonary function.
As a precaution, patients must be monitored for lung function, said Dan Lorber, a New York endocrinologist who was among the investigators involved in the drug studies.
Some endocrinologists are pleased that patients who may benefit from the drug would no longer have to plan their doses of insulin in advance of meals. Nor would they have to refrigerate it.
Farhad Zangeneh, an endocrinologist in Sterling, Va., began his first patient on Afrezza in March. The patient had long-standing, poorly controlled Type 2 diabetes, despite a daily long-acting injection, multiple pills, a good diet and exercise. Even that one shot was hard, as he deeply feared needles. Rather than amp up the injections, Zangeneh prescribed Afrezza.
“His glucose profile improved immediately and he has not had hypoglycemia,” he said.
Zangeneh has his patients take classes to learn how to use the inhaler, how the drug works and what the alternatives are.
“I want to make sure they understand not only how to use Afrezza, but other options. Then, if they have no lung issues and do not smoke, if they prefer inhaled insulin, I have no reservations,” he said.
Natasa Janicic-Kahric, an endocrinologist at MedStar Georgetown University Hospital in Washington, just began her first patient on Afrezza. The patient was badly bruised from years of insulin injections, and consequently was not absorbing it well. Janicic-Kahric hopes the inhaled drug will be more readily used by her body. She is also discussing this option with several patients who say they’ve grown weary with multiple injections.
“The inhaled option is convenient,” she said. “But I would prefer to wait a little longer to conclude whether it is effective.”
Janicic-Kahric is not sure she will offer it to Type 1 patients, uncertain it can provide the precise glucose control they require, since it comes in prepackaged doses. With injections, patients can vary the amount of insulin they receive by tiny amounts.
“Type 1 diabetics are much more sensitive to insulin, and even one unit too high or low can have a significant impact,” she said. “I’m hoping with time we will have more dosing options. Then I would more readily prescribe for Type 1.”
Zangeneh said he, too, would rarely prescribe Afrezza for Type 1 diabetics. If they are averse to shots, he prefers that they use a pump, which delivers insulin through a catheter placed under the skin.
Some endocrinologists are pleased that patients who may benefit from the drug would no longer have to plan their doses of insulin in advance of meals. Nor would they have to refrigerate it.
“They can sit at a table anywhere, take their inhaled insulin, and begin to eat right away,” Janicic-Kahric said.
Afrezza’s wholesale cost is about double that of injected insulin. But it should not cost consumers more. The company commercializing it, Sanofi, caps co-pays at $30, said Stefan Schwarz, vice president and head of U.S. marketing for Afrezza at Sanofi.
Killion is hopeful that Afrezza will help with an ongoing balancing act.
“After I eat, my glucose can go from 120 to 280 in 45 minutes. When it starts to come down, my insulin kicks in, and sometimes I get sugar lows because I have inadvertently overcorrected. It lingers and affects the next dose. It seems you are always chasing highs,” she said.
“Based on the literature, this insulin tends to act more like how my body would if I didn’t have this illness.”
What makes Killion happiest is that insulin-dependent diabetics may have a choice besides sticking something into their bodies.
“This is for the rest of their lives, and it gets old, taking five, six shots a day. An option other than a needle is huge.”
