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Zenvia Phase III PBA Trial Completes Patient Enrollment
Posted @ 18-Mar-09 12:38 under MS, News by pmbTags: MS, News
Zenvia Pharmaceuticals announced that it has completed targeted enrollment of patients into the STAR trial, a confirmatory Phase III trial of Zenvia™ (dextromethorphan / quinidine [DM/Q]) in patients exhibiting signs and symptoms of pseudobulbar affect (PBA). The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on involuntary crying/laughing episodes rates.
“The completion of patient enrollment into the STAR trial is an important clinical milestone for Avanir,” said Dr. Randall Kaye, Avanir’s Chief Medical Officer. “We look forward to unblinding the data in the third calendar quarter of this year and plan to submit our complete response to the approvable letter in the first half of 2010.”
About The Star Trial
The STAR trial had a targeted enrollment of 120 patients with multiple sclerosis (MS) and 180 patients with amyotrophic lateral sclerosis (ALS) who exhibit signs and symptoms of PBA at approximately 50 sites in the U.S. and Latin America. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries. Secondary endpoints for this clinical trial include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score; 2) Neuropsychiatric Inventory Questionnaire (NPI-Q); 3) SF-36 Health Survey; 4) Beck Depression Inventory (BDI-II); and 5) Pain Rating Scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables. For more information visit http://www.pbatrial.com.
About Zenvia
Zenvia is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of PBA and diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for Zenvia in the treatment of PBA. The Company has initiated a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency’s approvable letter for Zenvia in the treatment of PBA. For more information about this trial visit, http://www.pbatrial.com, and for more information about the Agency’s SPA process, see http://www.fda.gov/cder/guidance/3764fnl.htm. In April 2007, AVANIR announced successfully meeting all primary endpoints in a Phase III study of Zenvia in DPN pain. In May 2008, the Company released top-line results of a formal PK study that identified alternative lower-dose quinidine formulations of Zenvia for DPN pain intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. AVANIR is now engaged in positive dialogue with the FDA under the SPA process regarding the design of the next Phase III study in DPN pain and overall program requirements.
About Avanir
AVANIR Pharmaceuticals is focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR’s products and product candidates address therapeutic markets that include the central nervous system, inflammation, and infectious diseases. AVANIR’s lead product candidate, Zenvia, is being developed for the treatment of PBA and DPN pain. AVANIR has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company’s first commercialized product, Abreva®, is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at http://www.avanir.com and further information about pseudobulbar affect can be found at http://www.PBAinfo.org.
[medical news today]
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