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Oral ketamine set for pivotal trials in resistant depression

New Zealand-based contract manufacturing organisation Douglas Pharmaceuticals – which sponsored the 329-patient BEDROC trial and supplied the ketamine tablets – is now planning a phase 3 programme that could support regulatory filings.

The results have been published in the journal Nature Medicine and showed that a 180 mg dose of extended-release ketamine (R-107) was able to achieve a statistically significant improvement in symptoms compared to a placebo, measured using the Montgomery–Asberg Depression Rating Scale (MADRS). Other dosages were not significantly more effective than control.

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