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Neurogen: Positive Results for the Dopamine Agonist Aplindore

Posted on: Thursday, 16 October 2008, 12:00 CDT

Neurogen's new dopamine agonist aplindore has shown positive results in Phase II trials in the treatment of Parkinson's disease and restless leg syndrome. Datamonitor estimates dopamine agonist sales in these indications were worth $1.5 billion in 2007. However, aplindore's clinical profile suggests that it could be more competitive in the restless leg syndrome than the Parkinson's disease market.

Neurogen has announced positive Phase II results for its investigational drug aplindore, in both restless leg syndrome (RLS) and Parkinson's disease (PD). In each clinical trial, Neurogen's dopamine partial agonist demonstrated significant efficacy versus placebo, and was generally well tolerated. In the RLS study, statistically significant efficacy was observed on the first day of dosing, which opens the possibility of dosing aplindore without prior titration in this indication. In addition, all tested single doses of aplindore induced a significant reduction in periodic limb movement index (PLMI) during sleep from baseline levels, and were well tolerated with incidence of adverse events similar to placebo doses. In the PD clinical trial, aplindore was administered twice daily and required a titration. Neurogen reported aplindore's significant efficacy for the three lowest dose regimens tested.

The dopamine agonist market in PD and RLS was worth a combined $1.5 billion across the seven major markets in 2007. This therapy class generated sales revenues of $1 billion in the PD market in 2007, and accounted for over 50% of PD-specific drug sales. Over the past four years, dopamine agonists have largely replaced the anticonvulsant gabapentin in the treatment of RLS, and in 2007 accounted for 90% of the sales revenue generated by this indication, driven by better response rates. Datamonitor believes there is room for additional dopamine agonists for use in both markets, where currently only two brands dominate sales: Boehringer Ingelheim's Mirapex (pramipexole) and GSK's Requip (ropinirole).

From the released clinical data, aplindore's clinical profile indicates that it could be more competitive against current and pipeline treatments in RLS than in the PD market. The PD market is expected to be dominated by once-daily controlled released reformulations of the leading brands, as a result of their improved convenience and perceived smoother dopamine receptor agonism. With a twice daily dosing schedule in this indication, aplindore will struggle to gain market share. However, in RLS, aplindore's once-daily administration is equivalent to the current market leaders Mirapex and Requip, and the possibility of dosing aplindore without prior titration could give Neurogen a competitive advantage in the RLS market.

Source: Datamonitor

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