Impax Laboratories, Inc 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. The company also is providing an update on its brand pharmaceutical product program, which resides in its Impax Pharmaceuticals Division.
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.
"We are very excited with the results of this study, and are planning to meet with the US Food and Drug Administration (FDA) in the fourth quarter of this year to discuss the results of this study and determine the next steps in the submission of a new drug application (NDA) for IPX056," said Larry Hsu, Ph D, president and chief executive officer of Impax Laboratories. "Such spasticity treatments represent a $1.6 billion market in the US and IPX056 may fill an unmet medical need in these patients."
The Impax Pharmaceuticals division of Impax Laboratories currently has two products in its development pipeline, directed to neurology as a therapeutic focus, with four other central nervous system (CNS) specific products undergoing feasibility assessment. The company filed an Investigational New Drug application for IPX066, a controlled-release formulation of Carbidopa/Levodopa in July 2008, and expects to initiate studies in Parkinson's disease patients by the end of this year and is targeting an NDA submission in mid-2011.
Michael Nestor, divisional president of Impax Pharmaceuticals said, "We are very pleased with the progress we have made in advancing our proprietary, brand products and expect to continue this progress with an expansion in our R&D staff this year. The CNS space is ideally suited to our core competency in drug delivery, as so many products are candidates for improved dosing and administration and the market is large and growing at almost 10 per cent annually, faster than the total US pharmaceutical market. In addition, the neurology market is readily addressable by a small and focused sales force, given the concentration of physicians writing prescriptions. We currently have 66 specialty sales representatives to market our products, and to serve as a contract force for others," Nestor added.
Impax Laboratories, is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of brand products.