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TOKYO, Japan | Mar 07, 2006 | Kyowa Hakko Kogyo Co., Ltd. located in Chiyoda-ku, Tokyo, (President: Dr. Yuzuru Matsuda) has completed three Phase III clinical studies of KW-6002 (Generic (INN) name: Istradefylline), an agent developed in-house for the treatment of Parkinson’s Disease.
Parkinson’s Disease is initiated by a shortage of the neurotransmitter dopamine in the brain, which causes an imbalance in the nervous system. This disease is treated mainly by dopamine replacement with L-DOPA. Long term therapy with L-DOPA is associated with the development of a shortening response to each dose. This is called gwearing-off phenomenon.
The three Phase III clinical studies were conducted in Parkinson’s Disease patients with gwearing off phenomenon on treatment with L-DOPA alone or L-DOPA administered concomitantly with other Parkinson’s Disease medications. Two studies were conducted in North America and one study was conducted in 14 countries of the EU/and other regions. In all three studies, the efficacy and safety of Istradefylline/KW-6002 were assessed. Istradefylline/KW-6002 was administered for 12-16 weeks. The primary endpoint was reduction in the percentage of awake time spent in the goff state, and it served as an indicator of the improvement in the gwearing off phenomenon.
One of the North American studies revealed a statistically significant reduction in the percentage of awake time spent in the goff state. The other North American study and the trial conducted in the EU/other regions did not demonstrate a significant reduction in percentage of awake time per day spent in the goff state compared with placebo patients, but showed a significant improvement or a trend toward improvement in one of the secondary endpoints, the motor function score, assessed using the Unified Parkinson’s Disease Rating Scale (UPDRS) subscore III. Istradefylline/KW-6002 showed a similar safety profile as previously reported in Phase II studies. Based on these results, together with the results of the Phase IIb program (also demonstrating a statistically significant reduction in the percentage of awake time per day spent in the off state), Kyowa Hakko intends to submit a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the latter half of this year.
Istradefylline/KW-6002 hasa specific antagonistic effect on the adenosine A2A receptor in the brain. Thiscompound is expected to be a novel antiparkinson drug and to contribute torelieving various symptoms in many patients with Parkinson’s Disease.
SOURCE: Kyowa Hakko Kogyo Co., Ltd. |
