New Smoking Cessation Drug Fails To Get FDA Approval

The refusal to approve the drug was not due to any safety concerns...

The market for antismoking medication is set to grow much over the next decade. More and more nations around the world are introducing legislation that prohibits smoking in public places and thus it is becoming increasingly unfashionable and socially unacceptable to smoke these days. People who are heavy smokers and who are heavily addicted to cigarettes obviously will turn to smoking cessation drugs to help them and as a result many different pharmaceutical companies have invested heavily in the development and research of producing these types of drug.

Bad news however was recently announced for the Biovail Corporation in America which was informed by the Food and Drug Administration that their smoking cessation medication failed to pass the required test by the notoriously stringent health authority. Biovail Corporation was banking heavily on this new smoking cessation drug and as a result its shares fell by fourteen percent when the news was announced. The new smoking cessation drug was to be an antidepressant also and was to contain a formulation of the compound bupropion.

The refusal to approve the drug was not due to any safety concerns but due to the reason that the design of the clinical and pharmacokinetic studies were not considered to be up to standard. It is therefore possible that sometime in the near future when the studies are done properly and according to the Food and Drug Administration’s recommendations this drug could appear on the market alongside Champix. Biovail commented that they would be meeting with Food and Drug Administration officials in the near future and hoped to work out some initiatives to get the drug eventually launched.

Champix is the only smoking cessation drug in the United Kingdom that has approval from the National Institute of Clinical Excellence which studies whether drugs are efficient and useful and gives its recommendations to the relevant health authorities around the country.