Thanks Rohan. So first, I’d like to discuss the PRISM II interim results which is the open-label study assessing NUEDEXTA for PBA secondary to stroke, dementia and TBI.
We enrolled the last patient with TBI and dementia on April 23, with a total of 134 patients. And the early data were presented at the Alzheimer’s Association International Conference just in this past couple of months in July actually.
A baseline that patients – the dementia cohort had a CNS LS score of 20.2 and had a median of 29 PBA episodes per week. At the end of the study period, the CNS LS had improved to 12.8 and this was highly statistically significant compared with baseline and the median number of PBA episodes decreased to only 5 per week.
At the end of the study, there were consistent improvements observed in other effectiveness measures including the patient global impression of change often reported by the caregiver, as well as the clinician global impression of change.
The NUEDEXTA, the safety and tolerability was consistent to what’s in our approved label. The initial data in PRISM II is consistent with benefits we saw in the pivotal Phase III trial in PBA and provides further evidence that NUEDEXTA offers relief from the debilitating conditions regardless of the underlying neurological ideology.
PRISM II continues to enroll patients with PBA secondary to stroke and traumatic brain injury which are two important causes of PBA. We look forward to reporting full data from the Alzheimer’s cohort in the coming months.
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