Adamas wins its first FDA OK, set­ting up mar­ket launch for a re­for­mu­lat­ed Parkin­son’s drug

More than a year af­ter Adamas $ADMS post­ed pos­i­tive re­sults from a piv­otal Phase III study of ADS-5102 — an ex­tend­ed-re­lease ver­sion of the gener­ic Parkin­son’s treat­ment aman­ta­dine — the com­pa­ny got a green light from the FDA to sell the ther­a­py.

The drug will be sold as Go­cov­ri.

Prob­a­bly not un­ex­pect­ed­ly, the drug was able to beat out a place­bo in sig­nif­i­cant­ly re­duc­ing the side ef­fects of Parkin­son’s. And the Emeryville, CA-based biotech boasts that this is the first and on­ly drug ap­proved for “dysk­i­ne­sia in pa­tients with Parkin­son’s dis­ease re­ceiv­ing lev­odopa-based ther­a­py” — an or­phan in­di­ca­tion. The ther­a­py is de­signed to help pa­tients who suf­fer from the sharp, in­vol­un­tary move­ment dis­or­der brought on by lev­odopa, com­mon­ly used to con­trol the dis­ease.

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