DISEASE CLASSIFICATION(S):
Amyotrophic Lateral Sclerosis(ALS)
NAME OF CLINICAL TRIAL/STUDY:
Zenvia (Neurodex) as Treatment for Emotional Lability - Open Label Study
TRIAL UPDATES:
December 2007
Results of this open-label study of Zenvia are undergoing analysis.
A phase 3, double-blind, placebo-controlled trial of Zenvia for pseudobulbar affect (also known as involuntary emotional expression disorder) in ALS and multiple sclerosis (MS) has opened. See Zenvia for PBA -- Phase 3 Trial for Safety, Tolerability and Efficacy In this new trial, Zenvia will be tested against a placebo (inactive substance), and neither investigators nor participants will know which substance each person is taking until after the results have been analyzed.
July 2007
A July 5, 2007, press release from Avanir Pharmaceuticals says the company’s recent sale of its antipsychotic drug FazaClo will allow it to direct more resources toward its Zenvia development program.
See “Avanir Pharmaceuticals Announces Sale of Fazaclo ...”
November 2006
The experimental drug Zenvia (formerly referred to as Neurodex), developed by Avanir Pharmaceuticals of San Diego for the treatment of unwanted emotional expression, won’t be approved by the U.S. Food and Drug Administration (FDA) until additional data on safety and effectiveness have been supplied, according to an Oct. 31, 2006, press release from Avanir.
The Avanir press release says the company anticipates scheduling a meeting with the FDA to discuss the agency’s additional requirements.
In addition, the release notes, Avanir “can not be certain that once it has met with the FDA, that it will choose to continue with the development of Zenvia as previously planned.”
“Unfortunately, it seems we may still have more work to do,” said James Berg, Vice President of Clinical and Regulatory Affairs at Avanir. “It makes me sorry for all of the people that could use this drug and need it.”
The trial below remains open until at least March 1, 2007.
June 2006
Avanir Pharmaceuticals was advised by the U.S. Food and Drug Administration (FDA) on June 19, 2006, that the FDA will delay making a decision about approval of Neurodex for emotional lability (now called “involuntary emotional expression disorder”) until Oct. 30, 2006. According to Avanir, the FDA needs more time to review the data from the recently completed study.
This trial will remain open until at least March 1, 2007.
February 2006
A new drug application (NDA) was submitted to the U.S. Food and Drug Administration for approval for Neurodex as a treatment for pseudobulbar affect in January 2006.
If approved, Avanir says it hopes to make the drug available to patients in the second half of 2006.
PURPOSE AND RATIONALE:
Emotional lability, or uncontrolled laughing or crying that does not match a person’s underlying emotions, can be “pseudobulbar affect,” a condition associated with a number of neurological disorders, including ALS.
Symptoms may or may not be provoked and are generally not associated with the social setting or the person's actual feelings. Between 15 percent and 45 percent of people with ALS may experience this condition. The biologic mechanisms of how and why pseudobulbar affect occurs are not well understood. For many patients and their families, these symptoms are distressing and can sometimes be embarrassing. There are no medications specifically indicated to treat this symptom.
Avanir Pharmaceuticals is working with the U.S. Food and Drug Administration (FDA) on a drug development program for AVP-923, or Neurodex, for the treatment of pseudobulbar affect.
On June 20, 2002, Avanir Pharmaceuticals of San Diego, Calif., announced positive results from a clinical trial that tested the safety and effectiveness of AVP-923 (Neurodex). AVP-923 decreased the severity and frequency of pseudobulbar episodes and improved quality of life. That study was completed in the summer of 2002 and included 140 patients with ALS.
The formal report of the results is published in the Oct. 26, 2004, issue of Neurology (see References, below).
Avanir is currently conducting a multicenter, open-label trial of AVP-923 for patients experiencing pseudobulbar affect. This trial will assess the safety of AVP-923 in patients over the period of one year. (In an open-label trial, in contrast to a “blinded” trial, participants and investigators know what drug everyone is taking and in what dosage.)
STUDY DETAILS:
A contract research organization, INC Research, of Raleigh, N.C., is overseeing the trial. Contact INC Research toll-free at (888) 255-5300.
OPENING DATES:
Apr 1 2003
CLOSING DATES:
Feb 1 2006
TARGET NUMBER OF PARTICIPANTS:
300
RECRUITMENT STATUS:
Closed
ELIGIBILITY REQUIREMENTS:
Inclusion Criteria
Participants can be male or female and must:
- be 18 to 75 years of age
- have a clinical diagnosis of pseudobulbar affect and either stroke damage, Alzheimer’s disease, multiple sclerosis or ALS
Exclusion Criteria
Participants must not:
- have a sensitivity to quinidine or any opiate drugs
- have a current or prior history of major psychiatric disturbance
- have been a participant in a trial within the past 30 days
- be pregnant or breast-feeding
PUBLICATIONS:
Brooks B.R., et al. Treatment of pseudobulbar affect in ALS with dextromethorphan/quinidine: a randomized trial. Neurology, vol. 63, no. 8, Oct. 26, 2004, pp. 1364-1370. PubMed Abstract
