Acne drug completes pivotal studies

Published: 1-Feb-2004
Regulatory


Atrix Laboratories' proprietary acne drug Atrisone (5% topical dapsone gel) has completed two pivotal Phase III clinical studies. More than 3,000 patients were enrolled in these double-blind, randomised, vehicle-controlled studies in the US and Canada.

'The databases have been locked, and preliminary data analyses are complete,' said Dr Steve Garrett, senior vice president of clinical research. 'We will be working diligently to assemble the New Drug Application (NDA) to submit to the US FDA in July.'

Dapsone, the active compound in Atrisone, is an antibiotic with independent anti-inflammatory activity, formulated using Atrix's SMP technology.

It is insoluble so has been commercially available only as an oral table. The SMP technology provides a platform for such drugs to be delivered topically at the site of disease.

In a co-development agreement, Fujisawa Healthcare, the North American subsidiary of Fujisawa Pharmaceutical, has licensed the marketing rights to Atrisone for acne and provided significant support for the development of the product.

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