Higher dose of Novartis' Stalveo cleared in USA

Swiss drug major Novartis says that the US Food and Drug Administration has approved a new, higher-dose strength of Stalevo (carbidopa, levodopa and entacapone) which is indicated for Parkinson's disease patients with signs and symptoms of end-of-dose wearing off.

The approval of Stalevo 200mg, which consists of 50mg carbidopa, 200mg levodopa, 200mg entacapone, provides physicians with greater dosing flexibility in the treatment of PD patients experiencing symptom re-emergence, Novartis noted, adding that the introduction of this new dosage strength may lessen the burden of managing multiple medications among patients and their caregivers.

Stalevo simplifies treatment because it combines levodopa, the most widely-used agent for treating PD, with carbidopa and entacapone to provide more consistent and reliable levels of levodopa to the brain. The addition of entacapone to levodopa delays the breakdown of levodopa and extends the duration of effect of each dose. The firm noted that Stalevo significantly improves PD patients' ability to control body movements and to perform basic functions, such as walking and dressing, compared to traditional levodopa therapy.