Exubera
Insulin Deliverer.
To reiterate what Exubera is - This is the first new form of insulin delivery since insulin started being injected in the 1920's.
It is a fast-acting powder formulation of human insulin that is inhaled into the lungs via the mouth before meals, where it mimics the bodies natural insulin response to food intake. The 'folded' inhaler is about the size of a torch and does not need batteries or electricity. A retractable tube extends from the body of the device making it much longer, it reaches from the chest to the mouth. It is easy to use and accurate in it's delivery of the dry powder, which comes in one- or three-milligram blister packs, which are inserted into the side of the inhaler device before it is triggered.
Interestingly it was found that one gets a significantly higher insulin exposure if you use three 1mg doses consecutively than using one 3mg pack.
Although hailed in the press as a device that allows diabetics to abandon injections this is not strictly accurate.
It will cover the short term needs after meals but not 24 hour ones required by Type 1 and some few Type2 diabetics. They will still need to give themselves injections of intermediate or long acting insulins.
It does provide an alternative for those adults who are reluctant to use the injection devices currently on the market and thus do not 'comply' with their insulin regimes or are reluctant to start using insulin that may benefit them.
Nektar developed the inhalers and the insulin in partnership with Pfizer. They now provide manufacturing support for the Exubera insulin and also make the insulin delivery devices while Pfizer controls the manufacturing of Exubera and the marketing of it.
The EC states that "Exubera has been approved for the treatment of adults with type 2 diabetes (greater than 18 years of age) not adequately controlled with oral antidiabetic agents and requiring insulin therapy.
Exubera is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting injectable insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns".
The FDA press release is here.
Pfizer did not file for FDA or EC approval for the use of Exubera by anyone under 18.
Trials done with children were stopped early because of concerns over the effect Exubera was having on their breathing.
In the trials, on 2,500 Type1 and 2 adult diabetics over a period of 20 months it was shown to be as effective as injected insulin in controlling blood glucose levels.
Side effects did occur, the most worrying being the one I stated originally, the decrease in lung function.
There were patients who experienced a mild cough that showed up soon after inhalation of the insulin. The longer they used Exubera the less often coughing occurred.
Shortness of breath, sore throat, and dry mouth were also experienced by some patients.
Pfizer, at the requirement of the FDA, will continue to study the long term effects of Exubera with regard to it's safety. They also intend to do further research into finding a possible way for those with lung diseases to use it safely.
Likewise they intend to restart studies in children, after they have consulted with the FDA.
As of now Exubera should not be used by any diabetic with asthma or any other disease that causes lung dysfunction, eg. bronchitis, or emphysema.
Even patients with no symptoms of lung problems should have their lung function checked before starting to use Exubera, and at 6 - 12 month intervals thereafter.
Smokers & those who have smoked during the last 6 months should not use it and if someone on Exubera starts smoking they should stop using it.
It should also not be used by pregnant diabetics.
According to Pfizer there is going to be extensive support and training for healthcare professionals in the effective use of Exubera so they are able to teach their patients how to use it properly.
Pfizer say they expect it to become available for sale by midyear. They have had state-of-the-art manufacturing facilities set up in Frankfurt, Germany and Terre Haute, Indiana, U.S for a while, just waiting for the go ahead from the regulatory bodies.
Analysts are predicting returns in billions of dollars from the sale of this product though that will depend on how it performs once used by the general population.
On Monday the 30th January 2006 a UK spokesman for Pfizer told APM (Agence de Presse Medicale ) that Exubera would first be launched in the UK in May, with the US not far behind.
Medical devices firm Bespak, based in Milton Keynes, Bedfordshire, UK, is apparently going to be one of two companies making the delivery devices.
Go here to find out more Nektar.com.
Or here DrugDevelopment-Technology.com.