SkyePharma PLC announced initiation of Phase III clinical trials of the oral controlled release formulation of GlaxoSmithKline's Requip (Ropinirole HCl). The new once daily formulation for Parkinson's disease has been developed utilizing SkyePharma's Geomatrix technology. Requip OCR is expected to simplify the treatment regime for patients using this drug, thus improving patient convenience and compliance.
Michael R.D. Ashton, SkyePharma's chief executive officer commented: "The initiation of the Phase III study represents a significant milestone in the development of Requip and validation of the therapeutic advances obtained by formulating major drugs with our Geomatrix oral drug delivery platform. Moreover, it brings yet another SkyePharma improved formulation closer to commercialization."
Requip is indicated for the treatment of Parkinson's disease, both as initial monotherapy in early stage patients and as adjunct therapy, with L-dopa, to control motor fluctuations. It was first launched in 1997 in the US and most European countries. Requip has been proven effective in controlling tremors, muscle stiffness and impaired balance associated with Parkinson's disease.
Parkinson's disease is a chronic, progressive disease in which the degeneration of nerve cells in the brain eventually impairs the ability to control body movements. The primary symptoms are tremors in the arms, legs, hands and face; rigidity or stiffness of the limbs and torso; slowness of movement; and impaired balance and co-ordination.