PHARMACY

Takeda: Dexilant, Prevacid have less inhibiting effects on Plavix’s efficacy than counterparts

BY Alaric DeArment

NEW ORLEANS — Studies have indicated that proton-pump inhibitors, used for treating gastroesophageal reflux disease, reduce the efficacy of a popular blood-thinning drug, but Takeda Pharmaceuticals North America announced on Tuesday the results of a new study indicating that its own PPIs may have less of an effect.

The 160-patient study, presented at the American College of Cardiology’s 2011 annual scientific session in New Orleans, indicated that Takeda’s Dexilant (dexlansoprazole) and Prevacid (lansoprazole) had less of an inhibiting effect on the efficacy of Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel) in healthy subjects than AstraZeneca’s PPI Nexium (esomeprazole).

“We conducted this study to look at the effect of select PPIs on Plavix and add to the growing body of evidence on the potential interaction between these drugs,” lead study investigator and Harvard Medical School professor of pediatrics Alan Michelson said. “We found that in healthy subjects, the co-administration of Plavix with dexlansoprazole or lansoprazole reduced the antiplatelet effect of Plavix less than the co-administration of Plavix with esomeprazole.”

According to studies, PPIs may inhibit the liver enzyme CYP2C19, which is involved in the body’s metabolism of Plavix, thus reducing the drug’s effectiveness. In November 2009, the FDA warned against using Plavix with prescription and OTC formulations of AstraZeneca’s Prilosec (omeprazole) in response to the findings.

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PHARMACY

Viramune XR approved by the FDA

BY Alaric DeArment

RIDGEFIELD, Conn. — The Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals’ single-pill antiretroviral for HIV-1 patients, BI said Tuesday.

The FDA approved Viramune XR (nevirapine), a single-pill, once-daily, extended-release formulation of nevirapine for use in combination with other antiretroviral drugs.

“With the approval of once-daily Viramune XR, patients in the [United States] now have the benefit of a new HIV treatment option for use in combination with their other HIV medications,” said Joseph Gathe, Baylor College of Medicine clinical instructor, who also served as the lead investigator of a study of the drug. “Physicians in the [United States] can now switch their current Viramune treatments to a once-daily product with demonstrated comparable safety and efficacy.”

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PHARMACY

Takeda tries to block Impax’s launch of generic Dexilant

BY Alaric DeArment

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

The application contained a Paragraph IV certification, a legal assertion that the patents covering Dexilant are invalid, unenforceable or not infringed. Takeda filed suit against Impax in the U.S. District Court for the Northern District of California on Friday to prevent the launch, Impax said.

Dexilant delayed-release capsules had sales of $20 million in the 30-mg strength and $261 million in the 60-mg strength during the 12 months ended in January, according to Wolters Kluwer Health.

Upon FDA approval, Impax expects entitlement to 180 days of market exclusivity in which to compete directly with Takeda’s branded version of the drug. Patents covering Dexilant are scheduled to expire in 2020, 2026 and 2027, according to FDA records.

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