Avanir Pharmaceuticals Announces Presentation of Positive Early Results from PRISM II Study
"These initial data showing reduced symptoms of pseudobulbar affect (PBA) in patients with PBA secondary to Alzheimer's and dementia are consistent with the benefits we saw in the pivotal phase III study, in PBA patients with ALS and MS, and provide further evidence that NUEDEXTA may offer relief from the debilitating episodes of PBA," said
"PBA can have a devastating impact on the lives of patients that are already suffering with neurologic disorders such as Alzheimer's disease and other dementias," said Stephen D'Amico, MD, CMD, medical director at
PRISM II assessed the safety and efficacy of NUEDEXTA in treating PBA in patients with Alzheimer's disease/dementia, stroke and TBI. While the Alzheimer's disease/dementia cohort is now fully enrolled at 134 patients, at the time of interim analysis 96 patients had evaluable safety data and 68 had effectiveness data (at least 30 treatment days). The study endpoints included a PBA symptom rating (
- At baseline patients had a mean CNS-LS score of 20.2 and were suffering from a median of 29 PBA episodes per week.
- At the end of the study period, mean CNS-LS improved to 12.8 (P<0.001 compared with baseline) and the median number of PBA episodes decreased to 5 per week.
- At the end of the treatment period, consistent improvement was observed in other effectiveness measures
- Mean QOL scores improved from 6.1 at baseline to 2.8 at endpoint (P<0.001)
- 77.8% of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C
- 79.3% of clinicians rated the patient to be much/very much improved on the CGI-C
- MMSE mean score improved by 0.4 points at end of study from a baseline of 19.0
- Adverse Events (AE) were reported by a total of 35 (36.5%) patients (6.3% treatment-related), most commonly headache (9.4%), urinary tract infection (5.2%), and diarrhea (4.2%). Eleven patients had serious AEs (only one deemed treatment-related). Thirteen patients discontinued for AEs. This AE profile was generally consistent with that observed in other trials of NUEDEXTA.
About PRISM II
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg dextromethorphan (DM) and 10 mg quinidine (Q) for treatment of PBA in patients with prevalent neurological conditions including Alzheimer's disease/dementia, stroke and traumatic brain injury over a 12 week period.
PRISM II is a nationwide, open-label, multicenter, 12-week study enrolling up to approximately 450 patients at approximately 100 study centers. Eligible patients are aged >18 years with a clinical diagnosis of PBA and baseline score >13 on the
Poster Presentation Details:
Title: PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA) in Pseudobulbar Affect (PBA) Secondary to Dementia, Stroke, or Traumatic Brain Injury (TBI): Early Results of the Alzheimer's Disease/Dementia Cohort
Poster Number: 45758
PBA is a neurologic condition in patients with neurologic disease and injury characterized by uncontrollable, disruptive laughing and/or crying outbursts that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and impairments in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing. For more information about PBA, please visit www.pbafacts.com.
The CNS-LS has been validated in ALS and MS patients.
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state.
Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at www.NUEDEXTA.com.
Avanir® and NUEDEXTA® are registered trademarks owned by
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the market demand for and acceptance of Avanir's products domestically and internationally, research, development such as continued enrollment and data generation for the PRISM II study, and commercialization of new products domestically and internationally, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the
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