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February 7, 2013
08:36 EDTAVNRAvanir Pharmaceuticals announces positive interim data from study with AVP-786
Avanir Pharmaceuticals announced that it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786, a drug product containing a deuterium modified form of dextromethorphan. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923. The company has requested a meeting with the FDA to discuss the full development path for AVP-786. Avanir also announced today that the company intends to modify the enrollment target of its ongoing phase II clinical study of AVP-923 in central neuropathic pain in multiple sclerosis to 200 patients. As a result of this change, the company now expects to have data from the PRIME study in the fourth calendar quarter of 2013.
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November 16, 2015
08:07 EDTAVNRConcert Pharmaceuticals achieves $2M milestone from Avanir
Concert Pharmaceuticals (CNCE) announced that it has achieved a $2M milestone under its development and license agreement with Avanir Pharmaceuticals (AVNR) for the progression of the clinical development of AVP-786. The milestone is a result of Avanir initiating dosing of patients in a Phase 3 clinical trial with AVP-786 for the treatment of agitation in patients with Alzheimer's disease. The collaboration agreement between Concert and Avanir provides Avanir with worldwide rights to develop and commercialize AVP-786 and other deuterium-modified dextromethorphan (d-DM) compounds. Under the agreement, Concert is eligible to receive additional milestone payments based upon achievement of certain predefined regulatory and commercial targets. Avanir will continue to have overall responsibility for research, development and commercialization of d-DM compounds, including AVP-786, and Concert is eligible to receive tiered royalties on worldwide sales of any products containing d-DM. The milestone announced today is the third development milestone Concert has earned under this agreement.
08:05 EDTAVNRAvanir initiates Phase III trial of AVP-786
Avanir announced initiation of enrollment into a phase III clinical trial evaluating AVP-786 for the treatment of agitation in patients with Alzheimer's disease. This is the first of two placebo-controlled phase III trials in the company's TRIAD program. Avanir Pharmaceuticals recently received Fast Track designation from the FDA for the development of AVP-786 for this indication. The phase III studies are multicenter, randomized, double-blind, placebo-controlled trials that will evaluate two doses of AVP-786 versus placebo over a period of 12-weeks. Endpoints in these studies will include the Cohen Mansfield Agitation Inventory, the agitation/aggression domain of the Neuropsychiatry Inventory (NPI), other domains of the NPI, measures of global clinical change, and measures of caregiver burden and quality of life. Standard safety measurements will also be performed. TRIAD-1 is expected to enroll approximately 380 patients in 60 centers in the United States. TRIAD-2 is expected to enroll approximately 325 patients in 50 centers in the U.S. and will begin later in 2015. In addition to these two U.S. based trials, there will be additional global trials that will be conducted as part of the TRIAD program. Avanir has also initiated a phase II study to assess the efficacy, safety and tolerability of AVP-786 for the treatment of symptoms associated with residual schizophrenia. This study is expected to enroll approximately 120 patients in the U.S. Additionally, Avanir is currently enrolling patients in a phase II study of AVP-786 for the adjunctive treatment of major depressive disorder. This study began in 2014 and is expected to complete enrollment in 2015.

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