NUEDEXTA® safety profile

Most common adverse reactions in the pivotal trial1

Adverse events occurring in ≥5% baseline of patients on NUEDEXTA and ≥2x placebo rate

  NUEDEXTA (n=107) Placebo (n=109)
Diarrhea 13% 6%
Dizziness 10% 5%
Cough 5% 2%
Vomiting 5% 1%
Asthenia 5% 2%
Peripheral edema 5% 1%
  • The incidence of falls with NUEDEXTA was similar to placebo; however, NUEDEXTA may cause dizziness1,2
  • Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls
  • Adverse events were generally mild to moderate in nature1,3

 

Adverse reactions leading to discontinuation1

The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) that led to discontinuation with the dextromethorphan hydrobromide 20 mg/quinidine sulfate 10 mg twice daily dose were muscle spasticity (3%), respiratory failure (1%), abdominal pain (2%), asthenia (2%), dizziness (2%), fall (1%), and muscle spasms (2%).

 

NUEDEXTA Adverse Events in PRISM II Open-Label Trial4

Frequency of adverse events (AEs) in >1% of patients: N=367 n (%)
Diarrhea 20 (5.4)
Headache 15 (4.1)
Urinary tract infection 10 (2.7)
Dizziness 9 (2.5)
Nausea 6 (1.6)
Fall 6 (1.6)
Fatigue 5 (1.4)
Somnolence 5 (1.4)
Study Description
 

90-day, open-label (uncontrolled) US trial in adult patients with dementia, stroke, or TBI. All patients had a clinical diagnosis of PBA and a CNS-LS score ≥13 at baseline.

  • Serious AEs were reported in 6.3%; none were considered treatment-related by investigators
  • Two deaths were reported during the course of the study (2 males aged 91 and 83 with dementia). After careful consideration by the investigators, both deaths were deemed not related to study drug
  • Reported AEs in PRISM II were generally consistent with the NUEDEXTA safety profile observed in the placebo-controlled clinical trials. For more information, refer to the Full Prescribing Information and Important Safety Information throughout this website
  • In total, 36 (9.8%) participants had AEs that led to study withdrawal, most commonly for diarrhea (8 [2.2%]), dizziness, affective lability, and agitation (3 [0.8%] each)
  • Most AEs were of mild or moderate intensity