Impax Pharmaceuticals Initiates Second Phase III Trial Of IPX066 In Parkinson's Disease

Main Category: Parkinson's Disease
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Oct 2009 - 1:00 PDT

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Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ:IPXL), announced that it has initiated a multinational Phase III trial of its late-stage drug candidate IPX066 in advanced Parkinson's disease (PD) patients. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and then sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management. This is the second of two Phase III studies designed to support marketing approval of IPX066 in Parkinson's disease. Impax Pharmaceuticals previously reported in June the initiation of the first Phase III study of IPX066 in naïve PD patients.

Michael Nestor, divisional president of Impax Pharmaceuticals said: "We are extremely pleased to start the second Phase III study for IPX066. This trial in patients with advanced PD includes significant input from the FDA into the study design." He added, "Impax Pharmaceuticals looks forward to the successful development of IPX066 and bringing its potential benefits to physicians who treat Parkinson's and their patients as quickly as possible."

About the ADVANCE-PD Phase III Study

- The ADVANCE-PD study (http://www.advance-pd.com) will evaluate the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations.

- The trial is expected to enroll approximately 420 subjects who will be on treatment for approximately 22 weeks.

- The trial will be conducted at multiple sites in North America and Europe.

- The primary endpoint is percentage of "off" time during waking hours.

- Additional endpoints include total "off" time, total "on" time with no troublesome dyskinesias, Unified Parkinson's Disease Rating Scale (UPDRS) and clinician and patient reported outcome measures, including quality of life scales.

The ADVANCE-PD trial in patients with advanced PD complements the APEX-PD Study , which commenced in April 2009 and is currently enrolling levodopa-naïve PD patients. APEX-PD is a randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 and is being conducted in North America and Europe. The ADVANCE-PD and APEX-PD trials follow the earlier announced successful Phase II study of IPX066 in Parkinson's patients.

About IPX066 and Parkinson's Disease (PD)

IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management. IPX066 has the potential to offer improved and more reliable control of PD symptoms, leading to clinically meaningful reductions in "off" time, a key objective in the management of PD. "Off-time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms. In addition, IPX066 extended release formulation is designed to reduce dosing frequency, enhancing patient convenience.

Parkinson's disease is a chronic neurodegenerative movement disorder affecting an estimated one million people in the U.S. About $1 billion per year is spent on medications to treat PD in the U.S.

Source
Impax Laboratories, Inc.