Jan 29 2006
The Food and Drug Administration (FDA) in the U.S. has given it's approval for the sale of a new drug to treat diabetes.
The drug is the first inhaled version of insulin to hit the market and is expected to offer, for some diabetics, an alternative to injecting insulin on a daily basis.
Exubera should be available by mid-year.
The drug Exubera is produced by Pfizer and has been approved for adults with either Type 1 or Type 2 diabetes.
It is expected to be a big earner for the drug company.
In the U.S. alone, in excess of 5 million Americans use insulin daily to manage their blood sugar levels and prevent complications such as heart disease, blindness and limb amputations.
It seems that Exubera is a short-acting powder form of insulin that can be taken before meals but is not a substitute for all of the insulin shots many patients need.
The majority of patients, including nearly all Type 1 diabetics, will still will need the long-acting insulin administered by injection.
According to Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, Exubera should not be used by smokers and will not replace all injectable insulin.
Smokers will be advised not to uses Exubera as the habit means more of the inhaled insulin enters their bloodstream, putting them at risk of an overdose.
Patients with lung conditions such as asthma or chronic obstructive pulmonary disease, are also being advised not to use the drug until more research indicates that inhaled insulin is safe for them.
According to the drug company the Exubera inhaler, which was invented by Nektar Therapeutics weighs about four ounces and is approximately the size of an eyeglass case when closed.
The drug does however have such side effects as coughing, shortness of breath, sore throat and dry mouth.
The FDA advises as with any form of insulin, that diabetics will still need to keep a close eye on their blood sugar and monitor their levels regularly.
Analysts believe the drug will be a success but the lack of long-term data on the safety of inhaled insulin could influence it's appeal.
Pfizer has promised to conduct further studies of Exubera's effects.
The drug company has also been granted U.S. approval for the cancer drug Sutent and several other companies are also said to be in the process of developing inhaled insulin products.