`
`1 of 1
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`NEWS PROFILE CONGRESS
`
`RESEARCH
`
`LITERATURE
`
`SALES FUMARATES
`
`PSORIASIS
`
`MULTIPLE SCLEROSIS
`
`CONTACT
`
`GALENICAL DEVELOPMENT | PIPELINE | STUDIES
`
` » EN » Research » Galenical Development
`
` search Language
`
`Galenic development
`
`First-Generation Product
`
`Since August 1994 preparations have been available containing fumaric acid derivatives as the
`active substance, that have been granted marketing authorisation by the Federal Institute for
`Drugs and Medical Devices (BfArM) in Germany for treatment of psoriasis. These preparations
`are administered in the form of enteric film-coated tablets. However there are patients in whom
`these tablets cause gastrointestinal symptoms, making further treatment problematic or
`impossible.
`
`Second-Generation Product
`
`For this reason another pharmaceutical form has been developed and at the same time a
`monosubstance has been used. This new development involves enteric-coated microtablets in
`capsules intended to guarantee a finer distribution in the gastrointestinal tract, in order to
`achieve better gastrointesinal tolerance. This has been confirmed by initial results from a pilot
`study. Other very positive results for the new product from the dose-finding study (Phase II)
`carried out in 2003 in Poland have already been presented at a conference. Additional studies
`(Phase III) are either in progress or are in the pipeline and we hope to be able to publish new
`data soon.
`
`Relevant Links
`
`- Pipeline
`
`© Fumapharm AG
`
`Legal Statement
`
`created by H2G Internetagentur
`
`http://web.archive.org/web/20050803080203/http://www.fumapharm.ch/EN/Research/Galenical_Development/index.php
`
`Page 1 of 2
`
`
`
`Fumapharm AG - Galenical Development
`
`1 of 1
`
`NEWS PROFILE CONGRESS
`
`RESEARCH
`
`LITERATURE
`
`SALES FUMARATES
`
`PSORIASIS
`
`MULTIPLE SCLEROSIS
`
`CONTACT
`
`GALENICAL DEVELOPMENT | PIPELINE | STUDIES
`
` » EN » Research » Galenical Development
`
` search Language
`
`Galenic development
`
`First-Generation Product
`
`Since August 1994 preparations have been available containing fumaric acid derivatives as the
`active substance, that have been granted marketing authorisation by the Federal Institute for
`Drugs and Medical Devices (BfArM) in Germany for treatment of psoriasis. These preparations
`are administered in the form of enteric film-coated tablets. However there are patients in whom
`these tablets cause gastrointestinal symptoms, making further treatment problematic or
`impossible.
`
`Second-Generation Product
`
`For this reason another pharmaceutical form has been developed and at the same time a
`monosubstance has been used. This new development involves enteric-coated microtablets in
`capsules intended to guarantee a finer distribution in the gastrointestinal tract, in order to
`achieve better gastrointesinal tolerance. This has been confirmed by initial results from a pilot
`study. Other very positive results for the new product from the dose-finding study (Phase II)
`carried out in 2003 in Poland have already been presented at a conference. Additional studies
`(Phase III) are either in progress or are in the pipeline and we hope to be able to publish new
`data soon.
`
`Relevant Links
`
`- Pipeline
`
`© Fumapharm AG
`
`Legal Statement
`
`created by H2G Internetagentur
`
`http://web.archive.org/web/20050803080203/http://www.fumapharm.ch/EN/Research/Galenical_Development/index.php
`
`Page 2 of 2
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