Avanir announced the publication of data from the PRISM II study that showed significant improvement of pseudobulbar affect (PBA) with Nuedexta (dextromethorphan HBr/quinidine sulfate) capsules in patients with Alzheimer’s disease (AD) and other dementias, stroke, and traumatic brain injury (TBI). The full study results are published in BMC Neurology.
Nuedexta is currently the only treatment approved by the Food and Drug Administration (FDA) for PBA. It combines an uncompetitive NMDA receptor antagonist and sigma-1 agonist and a CYP2D6 inhibitor.
PRISM II, an open-label, multicenter study (n=367), evaluated patients receiving Nuedexta for 12 weeks. The primary endpoint was change in PBA symptoms as measured by the Center for Neurologic Study-Lability Scale (CNS-LS). The data showed a significant improvement in the CNS-LS score from a mean 20.5 at baseline to 12.8 (P<0.001) at Day 90; this was consistent with results from the Phase 3 trial. Episodes of PBA were reduced by 72.6% (P<0.001) vs. baseline at Day 90. The number of episodes over the 7 days prior to study visit reduced from median 12 at baseline to 2. About one-third (35.5%) of patient experienced no PBA episodes at the 90-day endpoint.
Seventy-seven percent of patients were rated as “very much improved” or “much improved” by clinicians with regards to PBA symptoms.
Sanjay Dubé, MD, vice president clinical development R&D at Avanir said, “We now have safety and efficacy data for Nuedexta in five of the most common neurologic illnesses where PBA symptoms are present – ALS, MS, AD and other dementias, stroke and TBI.”
Nuedexta is available as 20mg/10mg strength capsules in 60-count bottles.