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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
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2 7 - 0 6 - 2 0 0 2 Nieuwe insulines: Exubera, Oralin, AERx en Emisphere
Omdat er wereldwijd steeds meer mensen met overgewicht rondlopen, stijgt het aantal suikerpatienten snel. Vooruitziende farmaceuten investeren daarom miljarden in onderzoek naar nieuwe insulines die patienten meer hoeven te injecteren. Op 15 juni vertelden de bedrijven op een bijeenkomst van de American Diabetic Association hoe ver ze daarbij al zijn opgeschoten.
Insulinepatches De resultaten vallen tegen. Het is wel mogelijk om insuline via een pleister in het lichaam te brengen maar dan gaat het om hoeveelheden die aanvulling behoeven. De pleisters, waar het Amerikaanse Emisphere Technologies nu proeven mee doet, werken twaalf uur. Effect is pas na een uur merkbaar.
Emisphere Een insuline in een pil, ontwikkeld door Emisphere Technologies als aanvulling op de patch. Maximaal effect tussen 30 en 50 minuten. Bij hogere doseringen verminderen de concentraties bloedsuiker en het C-peptide met vijftig procent.
Emisphere Technologies is gespecialiseerd in het verzinnen van manieren om medicijnen via de orale route toe te dienen. Het bedrijf onderzoekt onder meer technieken die groeihormoonpillen mogelijk moeten maken.
Oralin Oralin zit in een spray voor onder de tong. De Canadese farmaceut Generex Biotechnology Corporation, de maker van Oralin, duidt de spray aan als RapidMist. Vijftien 'pufjes' staan gelijk aan een subcutane insuline-injectie van 0,11 IE per kilo. De maker mikt op de diabetes-2 patienten die al Metformin krijgen maar daaraan niet genoeg hebben.
Generex is gespecialiseerd in buccale medicijnen die onder je tong moet innemen, waar het slijmvlies de stoffen opneemt.
Exubera Exubera is een insuline in poedervorm dat je moet inhaleren. Het is een vrij zwaar middel, bedoeld voor diabetespatienten die alleen nog maar reageren op echte insuline. Het werkt zonder ondersteuning van andere medicijnen. Dit preparaat zou wel eens als eerste alternatieve insuline op de markt kunnen komen. De samenwerkende fabrikanten, Pfizer en Aventis Pharma, zijn bezig met fase-3 trials.
AERx Spreek uit: erreks. AERx is geen insulinepreparaat, maar een procede om medicijnen in vloeibare vorm via de longen toe te dienen. Ontwikkelaar is Aradigm, dat ook meer werkt aan een manier om testosteron langs deze route toe te dienen. Aradigm voert het insulineproject uit voor zakenpartner en insulineproducent Novo Nordisk.
1. Laurie Barclay.
Insuline Patch May Help Diabetics Dodge the Needle.
WebMD, 17-6-2002.
Lilly, partner forge ahead to perfect elusive insulin inhaler
Indianapolis Star Eli Lilly and Co.'s lagging attempt to develop an insulin inhaler picked up steam Tuesday as the drugmaker said it will make a "significant investment" in the project with a smaller partner. The investment, the size of which wasn't divulged, comes after a test of the device on patients with diabetes that Lilly said was successful. "We've been enthusiastic about this," said Dr. Douglas B. Muchmore, a Lilly medical fellow who leads the project's medical development team. "The company is prepared to put significant backing" into the project, he said. The Indianapolis drugmaker has been working since 2001 with Alkermes Inc., a small, publicly traded firm in Cambridge, Mass., to develop the insulin inhaler. Two other collaborations are further along in the race to put the first insulin inhaler on the market, but they have lately run into snags. European regulators this week told a three-way partnership of Pfizer, Aventis and Nektar Therapeutics they have concerns about approving their device. Lilly's chief rival in insulin sales, Novo Nordisk of Denmark, cut short a last-phase patient test this spring because of less-than-desirable results. The Lilly-Alkermes project is in the second of three phases of testing on humans. Lilly won't say how much longer the tests will run. Muchmore said he thinks the Lilly-Alkermes device will be "smaller, more portable, easier to use and less expensive" than competitive devices he's seen. Lilly in recent years has dominated insulin sales in the United States, with more than 80 percent of the market. Results of the Lilly-Alkermes phase-two tests on 120 diabetic patients showed that those who used the inhaler had similar success controlling their blood-sugar levels as patients who injected insulin, Alkermes officials said. Data from the study haven't yet been released. The device appears to be most useful for Type 2, or adult-onset diabetics, as a fast-acting, mealtime insulin, Muchmore said. The inhaler wouldn't be as useful for patients who need a long-lasting insulin supply, including while asleep. Those patients still would have to rely on injections, he said. Alkermes' stock surged $1.82 a share, to $10.33, after the Lilly announcement. Lilly's share price rose 59 cents, to $61.06. Lilly bought $30 million in preferred stock in Alkermes in 2002 and last year paid it $7 million for development costs. 0 9 - 0 9 - 2 0 0 5 FDA panel calls for approval of inhaled insulin
September 9, 2005 Federal health advisers yesterday recommended government approval of the first inhaled form of insulin, offering some diabetics an alternative to many of their daily injections. The recommendation by a Food and Drug Administration advisory panel was made despite questions about use of the drug among people who have lung disease or were exposed to secondhand smoke. No specific restrictions were recommended for Exubera, but FDA officials said smokers probably would not be able to use the drug. Their blood sugar level could fall dangerously low with Exubera because they absorb much more inhaled insulin in their lungs than do nonsmokers. Some advisers also were concerned that patients might not use the device properly. Drug company representatives suggested that the inhaler was not any more complicated than the injections many diabetics rely on. Panel members twice voted 7-2 to recommend FDA approval of Exubera for each of the two most common types of diabetes. The drug is being produced by Pfizer Inc., Sanofi-Aventis and Nektar Therapeutics. The FDA usually follows the recommendations of its advisory committees, but is not required to. The advisers questioned the drug companies about the long-term effects of distributing insulin to the body through the lungs, rather than directly into the bloodstream. Rebecca Wilkes Killion, a patient representative member of the committee, said inhaled insulin could persuade reluctant diabetics to take their medicine. "I take four shots a day, and the fourth one is the hardest one," Mrs. Killion said. "I'm tired of it. If I could get myself down to one, I'd be thrilled. A lot of people resist it because they are afraid of the needles." The companies, which are promoting Exubera as an easier-to-take alternative, proposed to conduct studies on the long-term effects of the drug until 2019. "We understand the need to assess the long-term effects on pulmonary function," said Dr. Neville Jackson of Pfizer. During drug trials, researchers found that inhaled insulin generally was as effective as injections in controlling blood sugar levels. Some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity. It is estimated that more than 18 million people in the United States have diabetes, although some do not know it. Most have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. Sometimes this can be treated with pills instead of injections. Fewer than 10 percent have Type 1, a disorder in which the immune system attacks insulin-producing cells in the pancreas. Inhaled insulin could be used to manage blood sugar levels for people with either type of diabetes who need insulin injections before meals. The drug would not replace longer-acting insulin injections people with Type 1 diabetes need to take in the morning or before bed, according to FDA. 2 8 - 0 1 - 2 0 0 6 FDA approves inhaled insulin
Pfizer and San Carlos company collaborate to produce powdered form of hormone
Justin Gillis Washington -- The Food and Drug Administration on Friday approved an inhaled form of insulin, the first new way to get that hormone into the body since it was discovered in 1921 -- and a new treatment option for many of the 21 million Americans with diabetes. The approval fulfills an arduous scientific quest that spanned most of the 20th century and spilled over to the 21st. And it marks the biggest change in diabetes treatment in decades, one that doctors hope will lure a fair slice of the American population into their offices to talk about controlling blood sugar. The product poses long-term safety questions, though, and it's not clear whether it will be more expensive than standard insulin. Millions of Americans need treatment with insulin but don't get it because it involves frequent, painful needle sticks and injections. About 5 million take the hormone, but a high proportion inject themselves too few times during the day because it's so inconvenient. Doctors hope inhaled insulin will overcome some of that resistance, helping diabetics ward off a slew of medical problems that afflict those who don't control their disease. Studies show the new product, to be sold by Pfizer Inc. under the brand name Exubera, works and appears to be safe with short-term use. Patients who have used inhalers told researchers they prefer them to needles by a wide margin, according to studies sponsored by Pfizer. "I'm just flabbergasted at the number of people who really do seem to want this, and want it substantially," said Jay Skyler, a University of Miami doctor and one of the nation's leading diabetes experts. However, inhaled insulin causes minor declines in how much air the lungs can hold. Scientists consider that a signal that long-term use could pose risks, although that could take years to sort out. The FDA recommended that smokers and people with some types of lung disease, including asthma, avoid using the product. Exubera is approved only for people 18 or older, though studies in children are under way. Pfizer said the product wouldn't be available in most pharmacies until June or July. Exact prices haven't been set, but Vanessa Aristide, a Pfizer spokeswoman, said the product would be "priced competitively" with injected insulin. Pfizer is first to market with such a product, but others are under development. Pfizer's partner in the development of Exubera is a Bay Area biotechnology firm, Nektar Therapeutics of San Carlos. The technology to produce the inhalant, powdered form of insulin was the fruit of 20 years of research by scientists led by Nektar's co-founder, John Patton. The team had to produce insulin particles small enough to be propelled by a hand-held inhaler and to penetrate deep into the lungs, where the drug could be absorbed into the bloodstream. The powdered drug also had to be stable at room temperature. Nektar said it drew inspiration from engineering tactics used in food processing, the music industry, diesel carburetor design and scuba equipment manufacturing. "Exubera would not have been possible without Nektar's innovative scientists and engineers and also our partner, Pfizer, who worked with us and remained committed to our original dream of delivering this medical breakthrough to patients," said Patton. Friday's decision confronts millions of Americans -- diabetics make up 7 percent of the population -- with a complicated new strategic problem, requiring them to figure out how much long-range risk they're willing to incur for the convenience, and possibly greater disease control, of using inhaled insulin. "The issue comes down to: How do we all deal with uncertainty?" said Robert Rizza, a diabetes specialist at the Mayo Clinic and president of the American Diabetes Association. "We just don't know what the long-run safety record will be. Each person will now need to think very carefully about the potential benefits and the risks for them." |
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