Impax Laboratories has announced that IPX056, an investigational extended-release formulation of baclofen, has met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients.
In a 173-patient, placebo and active comparator-controlled double blind Phase III study with a seven-week open label follow on, IPX056 was shown to be effective versus placebo in reducing spasticity in multiple sclerosis patients.
IPX056 is an extended-release formulation of baclofen, the drug of choice in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.
Impax has also filed an investigational new drug application (NDA) for IPX066, a controlled-release formulation of Carbidopa/Levodopa in July 2008. The company expects to initiate studies in Parkinson’s disease patients by the end of 2008 and is targeting a new drug application submission in mid-2011.
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