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Archive for May, 2010

New Arthritis Drug Gets FDA Approval

Monday, May 3rd, 2010

FDA Dug Approval New Arthritis Drug Gets FDA ApprovalToday, a new arthritis drug manufactured by Pozen and AstraZeneca received FDA approval. The new drug Vimovo will combine the popular heart burn drug Nexium with a generic pain killer.

Vimovo will attempt to fill the need of a drug that can reduce the risk of stomach ulcers that usually accompany most commonly used pain killers. Vimovo is a combination of naproxen, an anti-inflammatory pain reliever, and Nexium.

According to WSJ.com,

Jefferies analyst Eun Yang projects peak annual sales of Vimovo at $300 million and expects it to launch in late summer, calling it a “modest” product for AstraZeneca.

Yang said Vimovo, as a combination product, mainly provides convenience to patients and could face insurance reimbursement challenges.

Combination drugs are not exactly groundbreaking but offer more convenience and sometimes are more cost effective and can be found in almost all drug categories. Some common combination drug examples are Lopressor (beta blocker/diuretic), Vytorin (ezetimibe/simvastatin), Avandamet (Metformin hydrochloride/rosiglitazone maleate), and Hyzaar (Losartan and hydrochlorothiazide).

Vimovo was approved to treat osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing non steroidal anti-inflammatory drug-associated gastric ulcers. The pill is to be taken twice daily.

In a clinical trial of the drug, there was a 4.1% incidence of ulcers in Vimovo patients, compared to 23.1% among patients taking a coated form of naproxen. In a second similarly structured study, the incidence was 7.1%, compared to 24.3%.

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