FDA rejects Amneal’s extended-release Parkinson’s treatment, seeking more safety data

The FDA has re­ject­ed spe­cial­ty phar­ma and gener­ics mak­er Am­neal Phar­ma­ceu­ti­cals’ ex­tend­ed-re­lease cap­sule for Parkin­son’s dis­ease, which com­bines two drugs that have long been used to treat the neu­ro con­di­tion.

The drug, IPX203, is a new for­mu­la­tion of lev­odopa and car­bidopa. In the com­plete re­sponse let­ter, the FDA ac­knowl­edged an “ad­e­quate sci­en­tif­ic bridge” for the safe­ty of lev­odopa based on phar­ma­co­ki­net­ic stud­ies, but said safe­ty was not ad­e­quate­ly es­tab­lished for car­bidopa, ac­cord­ing to Am­neal.

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