Polpharma API characteristics:

• Crystalline anhydrous modification A1, same as originator
• Impurity profile control strategy based on optimum number of steps and materials selection

Drug description:

Safinamide is an alpha-aminoamide derivative acts as add-on therapy to dopamine agonists or levodopa.
Safinamide is indicated in the treatment of idiopathic Parkinson’s disease (PD) or for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products.
It is formulated as film-coated tablets for oral route of administration.

Mechanism of action:

Safinamide has a dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of excessive release of glutamate.