US drugmaker Pfizer Inc. has launched its first-of-its-kind arthritis drug, the arthritis drug Ibuprofen, for the first time.
Pfizer Inc. is planning a clinical trial that will test the drug's effectiveness against an assortment of different types of arthritis, including that that afflicts millions of American adults, according to a statement on its website.
The US-based company, which has received final approval from the European Commission for the drug, has now launched its first-of-its-kind arthritis drug, the arthritis drug Ibuprofen, for the first time.
The trial is the first in a new class of arthritis drugs called nonsteroidal anti-inflammatory drugs, or NSAIDS, and is the first time a company has tested ibuprofen on the new class. Ibuprofen is the only drug approved by the US Food and Drug Administration to treat arthritis in the first instance.
The company said it has "high confidence" that the arthritis drugs will be effective against the types of arthritis that afflicts millions of Americans, including that that that occurs in the middle of the United States.
"We are currently evaluating the potential of ibuprofen as a treatment option for osteoarthritis of the hands and knees and to a lesser degree to a lesser degree for rheumatoid arthritis of the hands and knees," the company said in a statement.
The company is also working on a trial to test the drug's effectiveness against other types of arthritis that affect the hands and knees.
The trial, which will run by the FDA from January 2009 to March 2010, is being conducted to evaluate the drug's safety and effectiveness in treating osteoarthritis and rheumatoid arthritis.
"While the efficacy of ibuprofen in osteoarthritis and rheumatoid arthritis is currently not yet well established, the results of the trial suggest that it may be a safe and effective treatment option for patients with these conditions," said FDA Commissioner Margaret Chan.
The trial, which has already begun, will be conducted by the FDA and the company will continue to monitor the results of the study as it continues to develop new drugs for pain relief.
Patients and their physicians can expect to see results in the next few months, including a trial that will be completed that will look at how the drug affects the cartilage of the joints and how the drug affects the cartilage in other areas of the body.
Pfizer said the drug, which will be sold under the name Ibuprofen, will be available in the US only by prescription, while the company will sell the drug in other countries, including Canada and elsewhere.
The company said it is currently evaluating whether the drug's effectiveness against other types of arthritis may be better than that of ibuprofen.
The company has been asked by a panel of regulatory agencies to conduct a preliminary trial to test the drug's safety and effectiveness in treating osteoarthritis and rheumatoid arthritis.
The panel of regulators will also weigh in on the effectiveness of the drug against a range of other similar types of arthritis, including that that afflicts millions of Americans, according to the company.
The drug will be sold in the United States, Canada, Mexico, Brazil and Canada as well as abroad.
Pfizer is currently testing a range of other nonsteroidal anti-inflammatory drugs, including a drug that was originally developed in the 1970s and which was the first to be approved by the FDA in the United States in 1985. Pfizer said it has not yet tested its drug in the United States.
Pfizer has already announced that it would begin an initial trial of its drug, which will be based on results of the Phase 2 clinical trial, in late June.
In addition to the initial trial of Ibuprofen, the company has also started an experimental phase in which it will study the effects of ibuprofen on the cartilage of people who are known to have osteoarthritis.
The company is currently evaluating the drug's effectiveness against other types of arthritis, including that that afflicts millions of Americans, according to the company.
The company's clinical trial is scheduled to run in late July or early August.
Image credit: © iStock/Getty ImagesPfizer's Ibuprofen, is one of the first drugs to be approved by the FDA to treat arthritis in the first instance, according to the company's website.
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Treatment of adults with non-prescription fever or other associated pain with the combination of Ibuprofen 200mg and Ibuprofen 300mg tablets is indicated for the short-term relief of fever and pain.
In adults with non-prescription fever or other associated pain with the combination of Ibuprofen 200mg and Ibuprofen 300mg tablets, Ibuprofen 600mg and ibuprofen 400mg tablets are indicated. Ibuprofen is one of the non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation, and works by inhibiting the production of prostaglandins, substances in the body that cause inflammation. Ibuprofen tablets are used for the short-term treatment of pain and fever.
Follow all directions given to you by your pharmacist or doctor carefully.
Adults: Take 1 or 2 tablets every 4 to 6 hours as necessary (maximum 6 tablets in 24 hours). Continue taking this medicine for the full duration as long as your doctor has prescribed.
Children: Avoid using the medicine by mouth. If your child experiences signs such as being sick (abnormal or persistent vomiting), getting up to speak to you or taking milk or water may help the pain or fever go away.
Store ibuprofen tablets at room temperature, 30°C to 50°C (59°F to 86°F). Do not exceed 72 hours. Store the medicine at room temperature ( excursions 25° - 30°C to 40°C). Store the medicine away from heat, moisture, and direct sunlight.
Active ingredient: Ibuprofen 200mg.
The usual dose is 50 mg of Ibuprofen, taken as 100-200 tablets (200 mg each).
Do not use:
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. This medicine is best taken on an empty stomach, at least 1 hour before or 2 hours after eating a meal.
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The physiological and the pathological changes of the body occur through the following mechanisms:
Bayer AG has halted the sale of the drug in Britain, saying it could be linked to a potentially fatal liver-related side effect. British drug maker Bayer will not say how the company is reacting to the news.
The news came as Bayer’s patent on the pain-relieving drug, sold under the brand name Panadol, expires in June 2018.
In the UK, the drugmaker has been trying to halt sales of the drug, which contains ibuprofen, but has not received any approvals. The decision to sell Panadol was made after the Food and Drug Administration warned British drug maker GlaxoSmithKline that it was potentially linked to a rare form of the liver problem.
The warning came after a study found that more than half of children taking the medicine were at risk of developing the condition. It has been reported that people who took the drug took a higher dose than those on the placebo.
Bayer said: “Bayer’s decision to stop the sale of Panadol in Britain will have no impact on its UK patent on this medication, which expires in April 2018. The company is committed to the safety of Panadol and will continue to work closely with its UK patent portfolio holders to protect UK medicines.”
Bayer said it was continuing to work with its UK patent holders to “ensure that the UK patent on Panadol will not expire in April 2018”.
Bayer, which is based in San Diego, USA, announced last month that it had reached an agreement with GlaxoSmithKline to sell the pain-relieving drug in the US. It will be made available to customers in January, and will be priced at £35.99 for a supply of 60 tablets.
The company said it had reached a deal with the US Food and Drug Administration to make the product available for sale in the US.
Bayer said it had reached an agreement with GlaxoSmithKline to make the product available in the US.
Bayer, which has been in the business of developing and selling prescription drugs for the treatment of pain and fever, will not be making any changes to the product name or packaging.
Bayer said it had agreed with GlaxoSmithKline to sell the product in the US. It had also said it would be buying the product from a supplier in the UK.
Bayer’s patent on Panadol, which expires in April 2018, will be sold in Britain and will be priced at £35.99 for a supply of 60 tablets.Bayer said it had reached an agreement with GlaxoSmithKline to sell the product in the US.
Bayer said it was continuing to work with its UK patent holders to ensure “the UK product remains as safe and effective as possible for the consumer as it is for other countries.”
Bayer said it was working with GlaxoSmithKline to “ensure that the UK product remains as safe and effective as possible for the consumer as it is for other countries”.
Bayer said it had reached a deal with GlaxoSmithKline to sell the product in the US.
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