Drugs/Therapy
ROG’s Schizophrenia Drug Bitopertin At Risk After Failing in Two Trials
An experimental schizophrenia drug bitopertin manufactured by Roche Holding AG has failed in two of the six final-stage patient trials, putting its future at risk.
In an emailed statement to Bloomberg Businessweek, the Switzerland-based drug maker said adding bitopertin to an anti-psychotic therapy did not help patients in overcoming negative symptoms such as social withdrawal and lack of motivation more than placebo after 6 months of treatment.
ROG's drug bitopertin will become the first schizophrenia drug to treat negative symptoms of the disease. The company said it will wait for data from trials that are still in progress, before reaching to a decision to abandon the product. The drug has also been the closest drug candidate to get an approval in its neuroscience program.
According to Andrew Weiss, an analyst for Bank Vontobel in Zurich, the schizophrenia medicine would have generated as much as 2 billion Swiss francs ($2.19 billion) in annual sales, Bloomberg reported.
"It is inherently high risk," told Weiss, according to Bloomberg. "Negative symptoms are inherently very difficult to assess. You're trying to assess mood."
"Without more information about patient outcomes on different doses of bitopertin, it's difficult to tell whether the drug's development will be delayed or halted entirely," he added.
Apart from running three studies on the drug's effects on negative symptoms, the company is also organizing three more trials that will look at whether it could help patients whose hallucinations and delusions linger despite treatment with anti-psychotic medications.
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