'Super-Aspirin' To Hit Market

The government has approved a new painkiller that could provide stiff competition to one of the nation's best-selling drugs.

Approval of Merck & Co.'s Vioxx was announced Friday, and the company said the drug should be in pharmacies by mid-June.

The Food and Drug Administration said it approved Vioxx for people with osteoarthritis, for women with menstrual pain and for adults with other acute pain.

The dosage is once a day, and the cost of the prescription medication is expected to be between $2.38 and $2.52 per tablet. It will also be available in liquid form.

In the tests on acute pain, Merck officials said the drug was tested and worked well on patients following extraction of wisdom teeth, people who had had hip or knee replacements and women who suffered severe menstrual pain.

Vioxx is a type of drug known as a Cox-2 inhibitor and is the second such drug on the market. The other, Monsanto's Celebrex, went on sale late last year for arthritis sufferers, and more than two million prescriptions were written in the first three months of sale.

Advisers to the FDA recommended approval of Vioxx last month.

Cox-2 inhibitors are a new type of drug that relieves aches and inflammation with fewer stomach-damaging side effects.

Millions of people depend on aspirin, ibuprofen, naproxen and other pills called "non-steroidal anti-inflammatory drugs," or NSAIDs, to relieve pain.

But NSAIDs can cause ulcers, stomach bleeding and other gastrointestinal side effects, especially in long-term users. They are blamed for causing 107,000 hospitalizations every year, and for killing 16,500 people.

NSAIDS target an enzyme called cyclo-oxegenase, which is responsible for much inflammation. But there are two types of this enzyme. Cox-2 is believed to cause inflammation, while Cox-1 protects the stomach lining. NSAIDs attack both.

So scientists developed more specific drugs to target just Cox-2.

While Vioxx is the second Cox-2 inhibitor on the market it could prove to be a formidable competitor, especially since it was approved for more uses than Celebrex.

Vioxx will include a label note that there were rare instances of gastrointestinal bleeding among users during trials and an alert, urging physicians to watch for that possibility.

Written By Randolph E. Schmid