'''Exubera''' is the brand name of first formulation of
inhalable insulin to receive the US
Food and Drug Administration (FDA) approval.
[1]
It is manufactured by
Pfizer in collaboration with
Nektar Therapeutics and is licensed for use by both
type 1 and
type 2 diabetics. However in the
UK its use in under the
National Health Service ''"should not be recommended because it could not be proven to be more clinically or cost effective than existing treatments"'',
[2]
except under special circumstances.
[3]
Pharmacology
Exubera is considered a short or rapid acting insulin. In clinical studies, Exubera reached peak concentration levels faster than some insulins administered by injection.
Thus, this form of insulin would begin working within the body faster than insulin that is injected. Type 1 and 2 diabetics will still need an injection of longer acting insulin to maintain a basal level for a 24 hour period.
Exubera works by using the strategy of reducing the particle size of insulin and making it into a dry powder so that it can get absorbed in the lung. It comes in two strengths, which are one and three milligram blisters.
[4]
These blisters are inserted into an inhaler for use. The insulin is then delivered to the lungs through the mouth.
Indications
Exubera is only indicated for use in patients over the age of 18, though studies in children are underway.
[5]
It is not recommended if you smoke or have stopped smoking less than 6 months ago.
4
In addition, people with certain type of lung disease, those who are pregnant or may become pregnant should not take Exubera.
[6]
Side effects
Some of the side effects of taking Exubera include cough, dry mouth and chest discomfort.
[7]
Because Exubera is inhaled, it may cause minor declines in how much air the lungs can hold, which lowers lung functions.
Scientists consider this a sign that long-term use could pose risks.
Before taking Exubera, a breathing test is necessary and additional tests will be needed during use.
Dosing concerns
Concerns have been expressed by the Institute for Safe Medication Practices about a serious risk of dosing errors when prescribing Exubera.
[8]
Insulin is traditionally prescribed in international units, but Exubera is prescribed in milligrams. 1 mg of Exubera is equivalent to 3 units of insulin, however, the increment is not linear: 3 mg of Exubera is equivalent to 8 units of insulin and not 9 units as might be expected, and the prescriber is strongly advised to refer to the manufacturer's conversion table before prescribing. Furthermore, because of retention of blister contents, three consecutive doses of 1mg blisters of Exubera results in a higher dose of insulin than a single 3mg blister of Exubera, further complicating prescribing calculations.
History and development
Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA, states:
"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition. It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.".
The following two paragraphs are excerpted from a Pfizer press release:
[9]
"The efficacy and safety profile of Exubera was studied in more than 2,500 adults with type 1 or type 2 diabetes for an average duration of 20 months. In clinical trials, many patients using Exubera reported greater treatment satisfaction than patients taking insulin by injection. Significantly more patients who had used both Exubera and insulin injections or diabetes pills reported an overall preference for Exubera. "
"In patients with type 2 diabetes, Exubera can be used alone as an alternative to rapid-acting insulin injections or diabetes pills, or in combination with diabetes pills or longer-acting insulin. In patients with type 1 diabetes, Exubera will be used in combination with longer-acting insulin."
Patent lawsuit by competing company
Novo Nordisk, a Danish diabetes pharmaceutical company and Pfizer competitor, filed suit against Pfizer on August 1, 2006, claiming patent infringement.
[10][11]
The lawsuit seeks both compensatory damages and
injunctive relief. Novo sought a preliminary injunction preventing the release of Pfizer's planned September 2006 launch of the diabetes drug. A federal judge, however, delayed any decision on Novo Nordisk's request for injunctive relief until at least December 4, 2006 when a court hearing is scheduled in the case.
[12]
Pfizer's answer contends that Novo wants to deny diabetics access to Exubera, the only FDA approved inhaled insulin, and interfere with the company's pharmaceutical business.
[13]
On
December 14,
2006 a federal
judge denied Novo Nordisk's request for a
preliminary injunction to halt sales of Pfizer's inhaled insulin.
[14]
The
patent lawsuit, however, has not been dismissed, and
Pfizer's legal defenses are preserved. The pharmaceutical companies are still litigating in court over their respective inhaled insulin
patent claims, a process that could take some time to resolve.
Footnotes
1. FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes
2. Diabetes inhaler rejected for NHS - Insulin that can be inhaled rather than injected has been rejected by NHS advisers on grounds of cost - cost of £1,100 per person per year.
3. Diabetes (type 1 and 2), Inhaled Insulin - Final Appraisal Determination
4. FDA Medication Guide for Exubera
5. FDA Approves Inhalable Insulin
6. First steps
7. Side effects
8. Insulin dosed in mg? A set up for errors!, Institute for Safe Medication Practices, , , Medication Safety Alert,
9.
10. Novo Nordisk sues Pfizer over Exubera patents
11. Novo-Nordisk A/S v. Pfizer, Inc. Exubera Patent Lawsuit
12. Pfizer-Novo Nordisk patent hearing set for December
13. Novo-Nordisk A/S v. Pfizer, Inc. Exubera Patent Lawsuit: Pfizer’s Answer
14. Judge denies motion to block sale of Pfizer's Exubera
External links
★ Nektar
Exubera description
★ Pfizer
Exubera website
★ FDA
Medication guide for Exubera
★ New England Journal of Medicine
[1] review article about Exubera
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