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ACADIA Pharmaceuticals Inc. Message Board

  • investormdpart2 investormdpart2 Apr 30, 2013 11:45 AM Flag

    fast track status

    Following up on my own message under 'Needham webcast' I would just point out that lesser programs in the Parkinson's space have been granted fast track status. See below (and this is just one example). Personally, I think they're going to apply for fast track.

    Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode of action in the treatment of Dyskinesia in Parkinson's Disease. The rationale behind the development of fipamezole is to increase noradrenergic release in certain areas of the brain, resulting in rebalancing of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations, orthostatic hypotension and cognitive impairment without exacerbating the underlying Parkinsonian features of the disease.

    In 2006, Santhera and Juvanita Pharma entered into a strategic cooperation to advance the development of fipamezole for the treatment of Dyskinesia in Parkinson's Disease. In summer 2009, Santhera reported posivie data from a confirmatory Phase IIb study, which demonstrated that fipamezole reduces Dyskinesia in Parkinson's Disease. The study results also suggest that the drug has the potential to reduce "off time" and improve cognitive function. Furthermore, the reduction in dyskinesia was found to be strongly correlated with the investigator's clinical global impression of improvement in overall condition.

    In August 2009, Santhera executed its call option to acquire all rights to fipamezole. Today, Santhera holds worldwide rights to develop and commercialize this first-in-class compound.

    Santhera has EU patent protection for the intended oromucosal formulation until 2023. The program was granted fast track designation status by the US Food and Drug Administration.

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