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The Committee for Medicinal Products for Human Use (CHMP) has approved Pramipexole Accord as a means of treating Parkinson’s disease.
The drug, which comes in 0.088mg, 0.18mg, 0.35mg, 0.7mg, 1.1mg doses, has been approved for use on its own or in combination with levodopa throughout the whole course of the disease – as a means of treating early signs and symptoms, through to the later stages when the effect of levodopa wears off or becomes inconsistent.
Pramipexole Accord is also indicated in adults for symptomatic treatment of moderate to sever idiopathic Restless Legs Syndrome in doses up to 0.54mg of base (0.75mg of salt).
The active substance of Pramipexole Accord is pramipexole as dihydrochloride monohydrate, which is a dopamine agonist (N04BC05) that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity.
Furthermore, pramipexole alleviates Parkinsonian motor symptoms by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits the dopamine synthesis, release, and turnover.
Pramipexole Accord is a generic of Mirapexin, which has been authorised in the EU since 23 February 1998. Studies have demonstrated the satisfactory quality of Pramipexole Accord and its bioequivalence with Mirapexin.
“The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Pramipexole Accord and therefore recommends the granting of the marketing authorisation,” stated the report.