Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ:IPXL), today 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