GlaxoSmithKline's Avandamet combination rosiglitazone/metformin product for diabetes is expected to be available in November, the company said after Oct. 10 FDA approval.

Avandamet is indicated "as an adjunct to diet and exercise to improve blood sugar control in people with type 2 diabetes who are already treated with rosiglitazone and metformin as separate tablets or who are not adequately controlled on metformin alone," labeling states.

The company is emphasizing the convenience of a rosiglitazone/metformin fixed-dose combination over taking GSK's Avandia (rosiglitazone) and metformin (Bristol's Glucophage and generics) separately. Patients will only need to refill one prescription and have a single copay for the combination product, GSK said. The company estimates that 30% of type II diabetics on thiazolidinediones also take metformin.

Avandia is approved in 2 mg, 4 mg and 8 mg tablets for use as monotherapy and in combination with metformin. The rosiglitazone/metformin tablets will be available in three strengths: 1 mg/500 mg, 2 mg/500 mg and 4 mg/500 mg.

GSK and Bristol-Myers Squibb ended their copromotion agreement for Avandia Aug. 20 (¹ Also see "GSK To Maintain Avandia Sales Rep Totals After Bristol Copromotion Ends" - Pink Sheet, 12 August, 2002., p. 32). GSK said it developed Avandamet without input from Bristol.

Avandamet approval was based on a bioequivalence study. "In a bioequivalence and dose proportionality study of Avandamet 4 mg/500 mg, both the rosiglitazone component and the metformin were equivalent to coadministered 4 mg rosiglitazone maleate tablet and 500 mg metformin hydrochloride tablet under fasted conditions," labeling states.

For patients inadequately controlled on metformin monotherapy, the recommended starting daily dose of Avandamet is 4 mg rosiglitazone and the current dose of metformin. If patients are inadequately controlled on rosiglitazone monotherapy, the starting dose of Avandamet is 1000 mg metformin and the current dose of rosiglitazone.

Bristol's antidiabetic Glucovance (glyburide and metformin) received supplemental approval Sept. 30 for use with a thiazolidinedione when glycemic control is not obtained with Glucovance alone.

GSK Avandamet Antidiabetic Combo Expected In Pharmacies In November

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