Boehringer Ingelheim Receives Positive Recommendation For Mirapexin

Published: 26-Jun-2009

Prolonged-release formulation is indicated for treatment of signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa

CHMP of the European Medicines Agency (EMEA) has issued a positive opinion about Boehringer Ingelheim’s Mirapexin/Sifrol (pramipexole). It has recommended the approval of once daily formulation for Mirapexin/Sifrol (pramipexole) in all countries of the EU, Norway, Iceland and Liechtenstein.

The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.

The CHMP recommendation follows clinical trial results confirming the high therapeutic benefits of Mirapexin/Sifrol, when administered in a convenient once-a-day formulation.

Dr. Manfred Haehl, Senior Vice-President of Medicine, Boehringer Ingelheim, said: “We are very pleased about the positive recommendation. This effective new treatment option combines the trusted clinical benefits of Mirapexin with the convenience of a single daily dose. The once daily administration of the new Mirapexin prolonged-release formulation has been shown to cause less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets.”

Once approved, PD patients already taking Mirapexin may be switched overnight from the immediate release tablets to the Mirapexin prolonged-release tablets, at the same daily dose. In addition to benefiting from the high therapeutic value of Mirapexin, the reduced pill burden will mean added convenience for patients and their carers. It is important for physicians to have effective and flexible treatment regimens to choose from so that they can offer individualised treatments in line with the patient’s needs,” he added.

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