Sumatriptan - Approval and Availability

Approval and Availability

Sumatriptan was the first clinically available triptan (in 1991). In the United States and most developed countries, it is available only by medical prescription. However, it can be bought over the counter in the UK in 50mg dosage. Several dosage forms for sumatriptan have been approved, including tablets, solution for injection, and nasal inhalers.

On April 15, 2008, the US FDA approved Treximet, a combination of sumatriptan and naproxen, an NSAID. This combination has shown a benefit over either medicine used separately.

In July 2009, the US FDA approved a single-use jet injector formulation of sumatriptan. The device delivers a subcutaneous injection of 6 mg sumatriptan, without the use of a needle. Autoinjectors with needles have been previously available in Europe and North America for several years.

Phase III studies with a iontophoretic transdermal patch (Zelrix) started in July 2008. This patch uses low voltage controlled by a pre-programmed microchip to deliver a single dose of sumatriptan through the skin within 30 minutes.

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