Product Pipeline
Our pipeline is focused on targeting significant unmet needs, with a primary focus on developing treatments for movement disorders in the field of neurolology.
IPX066
In December 2011, Impax filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX066, our lead branded pharmaceutical product candidate. IPX066 is an investigational, patented extended-release capsule formulation of carbidopa-levodopa (CD-LD) for the treatment of idiopathic Parkinson’s Disease (PD). IPX066 provides a rapid and sustained delivery of levodopa, with the goal of improving PD clinical symptom management.
The IPX066 NDA is being submitted as a 505(b)(2) application and includes data from three controlled Phase III studies and two open label extensions of IPX066 in early and advanced PD. The pivotal phase III studies of IPX066 include, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD). In these studies, IPX066 has been studied in about 900 PD subjects.
Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.
Impax plans to commercialize IPX066 in the U.S. with its specialty neurology sales team. IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) for territories outside the U.S. and Taiwan.
IPX066 Development Status
In December 2011, Impax submitted a New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson’s disease (PD). Impax is making commercial preparations to launch IPX066 in the U.S., pending U.S. FDA review and approval.
IPX066 Development Timeline – Formulation to FDA Filing in less than 4 years
Download the IPX066 Fact Sheet
IPX159
IPX159 is being developed by Impax Pharmaceuticals for the treatment of moderate to severe Restless Legs Syndrome (RLS). IPX159 is an investigational oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has completed a proof of concept study in RLS patients and started a Phase IIb study in RLS in December 2011.
RLS is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million Americans that experience RLS symptoms.1 Significant unmet need exists for alternative therapies to give physicians and their patients’ additional options and to help address the tolerability and safety issues with existing agents. IPX159 was found to reduce RLS symptom discomfort (SIT-VAS) and limb movements (SIT-PLMI) in a multicenter proof of concept study.2
IPX159 is intended to provide RLS sufferers a once-daily therapeutic option in RLS.
IPX159 Development Status
A Phase IIb study of IPX159 in moderate to severe RLS, commenced in December 2011 and results are planned to be available in mid-2013. Impax intends to develop IPX159 through the 505(b)(1) regulatory route of approval, which will yield a 5-year period of regulatory exclusivity on top of potential patent protection upon successful approval.
1. Datamonitor
2. Impax data on file
