Advances in nasal and pulmonary medicine application

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When first inhalation insulin was introduced in the market i wrote a article in the kolkata statesman edition 4 years back."Exubera might be the answer to a diabetic patient’s daily agonies, but then it might not work on every one of them, writes Amit Pachal HERE’S something for diabetic patients to cheer about. Soon there might be an alternative to the painfully invasive practice of taking insulin by injecting a needle into the patient’s vein. America’s Food and Drug Administration advisory committee panel has approved of an inhalable prompt-action dry powder insulin (r-DNA origin) for the treatment of type 1 (insulin dependent diabetes mellitus) and type 2 (non-insulin dependent diabetes mellitus) ailments. Exubera (a joint venture between Pfizer, Sanofi Aventis and Nector Therapeutics) is undoubtedly a boon for millions of diabetic people who regularly take insulin via needles and syringes to control blood sugar. The product acts much like inhalers already being used to control bronchial asthma and allergy. Fine, dry nebulised short-acting insulin is inhaled through a plastic device. Drugs administered through this route are quickly absorbed by the vast surface of alveoli and produce rapid systemic effect. Approximately 180 million people suffer from diabetes worldwide and within 20 years the number is supposed to touch the 300 million mark. According to World Health Organisation estimates, there were 19.4 million persons with diabetes in India in 1995 and the number is expected to rise to 57.2 million in 2025. According to American Academy of Clinical Endocrinologists, up to two-thirds of all diabetics are unable to adequately control their blood sugar. Uncontrolled hyperglycemia and hypertriglyceridaemia is associated with increased oxidative stress, which contributes to the development of microvascular and macrovascular complications — nephropathy, retinopathy and cardiovascular diseases. Insulin is a two-chain polypeptide having 51 amino acids and molecular weight 6000. Since the discovery of insulin in 1921 by Banting and Best; Exubera would be a major progress in insulin delivery. Most diabetes patients do not like to go through insulin therapy if they can help it. The reason being that injecting insulin on a regular basis entails having to modify one’s lifestyle, to say nothing of the pain and injection-related side effects. These are the reasons why often patients try deferring insulin therapy, sometimes even by five to 10 years. Given that oral insulin is degraded in the gastrointestinal tract by digestive enzymes, the first non-injectable insulin preparation available in the United States is expected to do a world of good to those who need it the most. Exubera, recently under review by the European Medicines Evaluations Agency, has been clinically trialled on more than 3500 patients, for more than seven years. M Mahoney, managing director, FDA Safety Official, is still doubtful about its efficacy in treating type 1 diabetes. “Questions remain as to whether adult type 1 diabetes can expect to achieve tight glycemic control with Exubera,†she has said. Exubera cannot be used by diabetics on long-acting insulin. It is likely to have an adverse effect on smokers. Damaged lungs make this insulin more bioavailable and could produce immediate hypoglycemia. Pfizer official, Neville , says they would be studying the effect of Exubera on lung patients for 12 years. “We understand the need to continue to assess the long-term effects of Exubera on pulmonary function,†he said. W Killion, a diabetic said, “I think the use of insulin without a needle … the siren call of that is almost irresistible.†Exubera is not recommended for adolescents and children as preliminary paediatric trials were postponed, due to uncertain adverse effects. The writer is a pharmacist with a renowned hospital."

But After Less Than 2 Years Weak Sales Lead to Exubera's Market Withdrawal

Pfizer pulls the first pulmonary insulin, but others are in the works

When the first inhalable insulin, Exubera, was approved for use by the U.S. Food and Drug Administration in January 2006, many anticipated that the product would revolutionize diabetes care by offering an alternative to insulin injections. But less than 2 years later, after sales paled in comparison to the billion-dollar payoff the company had been expecting, manufacturer Pfizer Inc. is taking Exubera off the market.

An October 18 statement from the company's chief medical officer, ph Feczko, MD, attributes this step to the fact that “too few patients are taking Exubera†and that other glucose-lowering alternatives exist.Amit PachalPharmacistCentral HospitalSouth Eastern RailwayKolkata-700043Kolkata