A Review of Levalbuterol (XOPENEX HFA) Inhaler for Asthma

Levalbuterol HFA (XOPENEX HFA) does not offer additional benefits over the older and less expensive drug albuterol (PROVENTIL, VENTOLIN) for treating asthma and other diseases, according to a March 2006 review from a highly respected medical publication.

The editors of the highly respected Medical Letter on Drugs and Therapeutics, known for their independence from drug companies, first reviewed levalbuterol in 1999. They concluded their evaluation by saying that there was “no clinically significant advantage” over albuterol. Almost six years later, in their March 13, 2006 issue, Medical Letter  reiterated those same sentiments in their review of levalbuterol HFA:

There is no convincing evidence that levalbuterol tartrate (XOPENEX HFA) offers any advantage over racemic [a technical term for the mixture of the two isomers of a drug] albuterol.  

Levalbuterol and albuterol, for all practical purposes, are the same drug. Chemically speaking, these drugs are isomers. An isomer is a molecule containing identical atoms to another molecule, but arranged differently: a mirror image, to be precise. Consider two isomers of a certain molecule to be like a pair of gloves – same number of fingers, just arranged differently.

Levabuterol comes in two forms: XOPENEX HFA, a pocket-sized medicated inhaler approved by the FDA in March 2005, and XOPENEX, a liquid drug that patients convert to a fine mist by passing it through a machine called a nebulizer. XOPENEX was FDA-approved in 1999.

Levalbuterol belongs to the family of asthma drugs known as short-acting beta agonists, which are used to relieve symptoms during an asthma attack. Levalbuterol was reviewed in the September 1999 issue of Worst Pills, Best Pills News and listed as a “DO NOT USE” drug because there was, and still is, no convincing evidence that it is any safer or more effective than the older, much less expensive short-acting beta agonist, albuterol.  

Levalbuterol is marketed by Sepracor Inc. of Marlborough, MA. In 2005, more than 2.2 million prescriptions for levalbuterol were dispensed at a cost of more than $293 million. This figure marks an increase of almost 22 percent from 2004 sales.

A “smoke and mirror (image)” business scheme
Selling a mirror-image molecule as a “new” drug is a successful business scheme, but it is not a strategy that necessarily produces better drugs or improves public health.  

In Public Citizen’s view, ”smoke and mirrors” aptly describes the technique Sepracor hopes to employ by marketing levalbuterol, The smoke consists of phony ‘breakthrough’ advertising, and the mirrors are represented by a chemical gimmick involving isomers. (See our article “Selling New Drugs Using Smoke and Mirror (Images)” in the March 2003 issue of Worst Pills, Best Pills News.)

Albuterol was first marketed in the United States in 1981 and has long since lost its patent protection. This has allowed a number of generic manufacturers of albuterol into the marketplace to compete on the basis of price.

However, Sepracor received a patent for an isomer of albuterol (levalbuterol), which allows the drug company to market what is essentially the same pill as a new drug – at a full brand-name price – and protect a monopoly position in the market for years to come. This is good for Sepracor investors but costs patients and the healthcare system much more.

A patient pays about $10.99 for one albuterol inhaler at a large chain pharmacy. For a person who needs a new inhaler every month, the one-year out-of-pocket expense would be $131.88. If the same patient switched to levalbuterol HFA, one inhaler would cost $48.99 and provide no therapeutic advantage, which means that person would spend $587.88 a year – $456 more than albuterol.

What You Can Do
If you are presently using albuterol and your asthma is adequately controlled, there is no medical reason why you should be switched to levalbuterol.