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avanir pharmaceuticals inc (AVNR) Snapshot

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avanir pharmaceuticals inc (AVNR) Details

Avanir Pharmaceuticals, Inc., together with its subsidiaries, is engaged in acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders primarily in the United States. It primarily offers NUEDEXTA, a dual N-methyl-D-aspartate receptor antagonist and sigma-1 agonist for the treatment of pseudobulbar affect; and Docosanol 10% cream, an over-the-counter product for the treatment of cold sores. The company’s clinical development stage products comprise AVP-923, which has completed Phase II clinical trials for the treatment of central neuropathic pain in patients with multiple sclerosis; is in Phase II clinical trials for the treatment of agitation in patients with Alzheimer’s disease; and is in Phase II clinical trials for the treatment of levodopa-induced-dyskinesia in Parkinson’s disease, as well as completed Phase III trials for the treatment of patients with diabetic peripheral neuropathic pain. It is also developing AVP-786, a Phase I clinical trial novel investigational drug product for the treatment of neurologic and psychiatric disorders; and AVP-825, an investigational drug-device combination product, which is in Phase III clinical trials, to treat acute migraine. The company has a license agreement with Concert Pharmaceuticals, Inc. to develop and commercialize deuterium-modified dextromethorphan for the potential treatment of neurologic and psychiatric disorders, as well as rights to other deuterium-modified dextromethorphan compounds; and a license agreement with OptiNose AS for the development and commercialization of a novel breath powered intranasal delivery system to treat acute migraine. Avanir Pharmaceuticals, Inc. was founded in 1988 and is headquartered in Aliso Viejo, California.

267 Employees
Last Reported Date: 12/11/13
Founded in 1988

avanir pharmaceuticals inc (AVNR) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $578.8K
Principal Financial Officer, Principal Accoun...
Total Annual Compensation: $260.1K
Chief Commercial Officer and Senior Vice Pres...
Total Annual Compensation: $371.5K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $362.2K
Compensation as of Fiscal Year 2013.

avanir pharmaceuticals inc (AVNR) Key Developments

Avanir Pharmaceuticals, Inc. Announces FDA Acceptance of New Drug Application for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder

Avanir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration accepted the company's Investigational New Drug application for a Phase II study assessing the safety and efficacy of AVP-786, Avanir's next generation compound. The company plans to initiate this study evaluating AVP-786 for the adjunctive treatment of major depressive disorder during the third calendar quarter of 2014.

Avanir Pharmaceuticals, Inc. Announces Presentation of Positive Early Results from PRISM II Study

Avanir Pharmaceuticals, Inc. announced interim data from the phase IV PRISM II study showing that treatment with NUEDEXTA substantially reduced symptoms of pseudobulbar affect (PBA) in patients with Alzheimer's disease/dementia. PBA is a distressing neurologic condition characterized by sudden and uncontrolled outbursts of laughing and/or crying in patients with neurologic disease and injury. A standard quality of life measure also showed clear improvement over the 3-month treatment period. 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 (Center for Neurologic Study-Lability Scale; CNS-LS; 7=no symptoms -- 35=maximum symptoms), number of weekly PBA episodes, Mini-Mental State Examination (MMSE), quality of life (QOL; 0=no impairment-10=maximum impairment) improvements, and Clinician and Patient Global Impression of Change (CGI-C; PGI-C). 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.

Avanir Pharmaceuticals, Inc. Announces Positive Outcome of Phase IIIb COMPASS Trial

Avanir Pharmaceuticals, Inc. announced that COMPASS, its Phase IIIb clinical trial comparing the efficacy and safety of the investigational product AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults, met the primary efficacy endpoint. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered(TM) delivery technology. In March 2014, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) of AVP-825 and the Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014. The COMPASS study met the primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30), showing that migraine sufferers achieved greater pain relief within 30 minutes of treatment with 22 mg of the investigational product AVP-825 compared with 100 mg sumatriptan tablet (p<0.0001). In addition, AVP-825 treated migraine sufferers achieved pain freedom in a greater proportion of migraine attacks at 15, 30, 45, 60 and 90 minutes post dose compared with those treated with sumatriptan tablet (p<0.05). In these topline data, several additional secondary endpoints relating to pain relief were also met. The overall safety profile of AVP-825, an investigational product, was consistent with that observed in previous trials, with less than 2% of subjects experiencing an adverse event leading to treatment discontinuation. There were no serious adverse events in the study. Nasal discomfort and abnormal product taste were more common with AVP-825 administration; these adverse events were deemed mild in nearly 90% of cases. The company plans to review the detailed data from the COMPASS study and present the full results at an upcoming medical meeting.


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