PHARMACY

FDA approves Treximet for acute migraine treatment

BY Adam Kraemer

LONDON GlaxoSmithKline and Pozen announced this week that the Food and Drug Administration has approved Treximet for the acute treatment of migraine attacks with or without aura in adults.

Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan—a class of migraine-specific medicines pioneered by GSK—and an anti-inflammatory pain reliever in a single tablet.

Treximet contains 85 mg sumatriptan, the active ingredient in Imitrex, and 500 mg naproxen sodium, which is most commonly marketed as painkiller Aleve.

“Migraine patients want their medicine to work early, and to continue to provide relief,” said one of the trial investigators, Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University. “The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients.”

The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.

Findings from these studies showed that Treximet was more effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours than either of its component medications alone. In addition, Treximet more effectively relieved migraine associated symptoms—nausea and sensitivity to light and sound—compared to a placebo.

Migraine headaches continue to be a significant problem for the estimated 29.5 million Americans, nearly half of which are undiagnosed, according to GSK. Recent research suggests that migraine involves a complex chain of events that are both neurovascular and inflammatory. The sumatriptan in Treximet mediates vasoconstriction, which correlates with the relief of migraine headache. The naproxen, meanwhile, acts as an anti-inflammatory agent. The combination, therefore, of sumatriptan and naproxen sodium contributes to the relief of migraine through pharmacologically different mechanisms of action, GSK stated.

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Major drug companies fight stronger restrictions on off-label marketing on drugs

BY Diana Alickaj

WASHINGTON Ten major drug companies have formed a coalition and will submit their arguments to the Food and Drug Administration to push for looser proposed restrictions on off-label marketing, according to published reports.

The 10 companies include Pfizer Inc., Bayer Corp., the U.S. unit of Bayer AG; AstraZenecaPLC; and Johnson & Johnson who will be represented by Daniel Troy a former FDA Chief Counsel and is currently working with APCO Worldwide Inc.

Merck & Co., according to two reports from the Journal of the American Medical Association, was reported to have not effectively marketed the risks of its painkiller, Vioxx, which reportedly served as a risk for heart attack to Alzheimer’s patients. Congressional investigators also have accused Merck and Schering PloughCorp, the makers of Vytorin, a cholesterol drug, of trying to withhold information that questioned the drug’s effectiveness. These two instances are one of many in which Congress is trying to place stronger restrictions on the companies marketing strategies for these drugs.

According to published reports, a poll conducted during an annual conference sponsored by the drug-marketing magazine DTC Perspectives stated that 60 percent of participants felt that Congress might place limits on TV advertising for pharmaceutical companies. Another idea that the drug companies are not in favor of is to place a telephone number in ads, so consumers can call the FDA  to express their problems with a specific drug.

According to published reports, the chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell already is taking this issue seriously by calling a hearing on direct-to-consumer advertising. In a statement regarding this issue,  Dingell said, “Drug companies should know that they would be held accountable for inappropriate behavior and inaccurate representations made in their ads.” The hearing is expected to take place in a few weeks.

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Roche acquires Piramed for $160 million

BY Adam Kraemer

ZURICH , Switzerland Roche Holdings said it will buy U.K.-based biotech firm Piramed for $160 million in an attempt to strengthen its oncology and arthritis pipelines.

An additional payment of $15 million is due upon the commencement of Phase II clinical trials for the company’s oncology program, the Swiss company said.

The final transaction value will be adjusted by the net cash balance remaining upon closing. Regulators are expected to approve the deal in the second quarter of 2008.

Piramed focuses on the development of PI3-K inhibitors, which are known to play an important role in halting disease progression and in preventing resistance to chemotherapeutics in cancer cells. Pre-clinical studies have demonstrated their potential importance in treating inflammatory diseases such as rheumatoid arthritis, Roche said.

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