GSK Parkinson’s drug shows motor skills benefits
pharmafile | August 16, 2011 | News story | Research and Development | GSK, Impax Pharmaceuticals, Parkinson's disease, research and development news
GlaxoSmithKline’s new drug IPX066 has helped Parkinson’s disease patients retain their motor skills after their medication wore off.
IPX066, which GSK licensed from Impax Pharmaceuticals, is an extended release capsule formulation of carbidopa-levodopa.
In a phase III trial it significantly extended a patients ‘off time’ when compared to Novartis/Orion’s standard treatment Stalevo (carbidopa, levodopa and entacapone – or CLE).
The primary endpoint of the ASCEND-PD study was the percentage of ‘off time’ during waking hours as measured by patient diary, which provides a measure of patients’ functional state after their medication has worn off and the motor symptoms of Parkinson’s return.
Patients entered the study with a baseline off time of 36.1% (5.9 hours), but by the end of treatment with IPX066 patients had an off time of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for those on Stalevo.
This represents a 33.5% decrease in percent off time for IPX066 from baseline, versus just a 10% decrease for CLE.
Dr Suneel Gupta, Impax Pharmaceuticals’ chief scientific officer, said: “Impax Pharmaceuticals and GSK are excited to report these positive results for the ASCEND-PD trial which demonstrate an 84-minute improvement in “off time” over CLE therapy with a corresponding increase in “on time” without troublesome dyskinesia.
Under a 2010 deal Impax holds the marketing rights for the drug in the US and Taiwan, whilst GSK holds the rights for every other market.
Both firms were equally encouraged by the data, with Impax saying it now plans to submit this week’s study as part of its new drug application for IPX066, which it will file with the FDA in the fourth quarter.
Meanwhile GSK said it plans to file the marketing authorisation application for the drug in Europe sometime next year.
The drug is an investigational extended release capsule formulation of carbidopa-levodopa, which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response.
Ben Adams
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