Osaka, Japan, January 8, 2015— Takeda Pharmaceutical Company Limited (“Takeda”) announced today the start of Phase 2/3 and Phase 3 clinical trials of rasagiline (generic name, development code: TVP-1012), an investigational compound for the treatment of Parkinson's disease, in Japan.
The main portion of clinical trials started this time aiming to examine efficacy and safety of rasagiline consists of a couple of multicenter, randomized, double-blind and placebo-controlled parallel-group comparative trials. One is a Phase 2/3 clinical trial conducted with the Japanese patients with Parkinson's disease under the treatment with levodopa (adjunctive therapy study), and its primary endpoint is change of mean total daily off-time*. Another is a Phase 3 clinical trial conducted with the Japanese patients with early stage Parkinson’s disease (monotherapy study), and its primary endpoint is sum of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) ** Parts 2 and 3 scores.
Developed by Teva Pharmaceutical Industries Ltd. (“Teva”), rasagiline is approved in 53 countries in Europe, the US and other regions for the treatment of Parkinson’s disease. Rasagiline is a monoamine oxidase B (MAO-B) inhibitor which acts by increasing available synaptic dopamine in the brain which may improve the motor symptoms characteristic of Parkinson’s disease. Teva and Takeda signed an agreement as of the end of March 2014, granting Takeda a right to commercialize rasagiline in Japan.
* Off-time refers to times when levodopa is not working well, causing worsening symptoms.
** MDS-UPDRS is Parkinson's disease assessment scale which is composed of four evaluation items, where Part 2 has 13 questions concerning the motor aspects of experiences of daily living and Part 3 has 18 subscales evaluating motor function.
Rasagiline is currently approved in 53 countries including the US, Canada, Israel, Mexico and various European countries. Both monotherapy and combination therapy with levodopa are approved as treatment of Parkinson’s disease overseas. Rasagiline can be used in combination with dopamine agonist, without levodopa, in the US. Worldwide sales in 2013 were USD 371 Million (Teva alone).
For details of approved labeling in the US and EU, please access the URL below:
About Parkinson’s disease
Parkinson's disease is a neurodegenerative disease associated with aging. General symptoms include tremor, akinesia, muscular rigidity, postural reflex disorder, and autonomic nervous system symptoms. It is estimated there are approximately 4 million worldwide, and 150,000 – 180,000 people in Japan diagnosed with Parkinson’s disease* which typically develops among those who are over 60 years of age.
* The Japanese treatment guideline on Parkinson’s disease 2011, supervised by the Japan Society of Neurology
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