Key Developments: Avanir Pharmaceuticals Inc (AVNR.O)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Avanir Pharmaceuticals Inc Announces Research Collaboration With Department Of Veterans Affairs For Screening Pseudobulbar Affect Symptoms In Veterans With Traumatic Brain Injury
Avanir Pharmaceuticals Inc announced that in collaboration with the Department of Veterans Affairs (VA) and United BioSource Corporation (UBC) announced a pilot study to screen for pseudobulbar affect (PBA) symptoms in approximately 1,000 veterans with traumatic brain injury (TBI) . According to The Bob Woodruff Foundation, it is estimated that more than 320,000 service members have sustained traumatic brain injuries. PBA occurs when a TBI or other neurological condition, such as multiple sclerosis, Lou Gehrig's disease (ALS), Parkinson's disease, stroke or Alzheimer's disease, damages the areas of the brain that controls normal emotional expression, causing uncontrollable episodes of crying or laughing. These outbursts are often contrary or exaggerated to the patient's inner emotional state, causing them to laugh or cry when they may not find the situation to be particularly funny or sad. As a result, many of those afflicted with PBA have impairment on measures of general health status, occupational and social function. People with PBA tend to have higher incidence of depressive symptoms and often avoid social activities they would normally enjoy. Full Article
Avanir Pharmaceuticals Inc Announces Positive Interim Data From Pharmacokinetic Study With Next Generation Compound AVP-786
Avanir Pharmaceuticals Inc 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 (dextromethorphan hydrobromide and quinidine sulfate). The Company has requested a meeting with the FDA to discuss the full development path for AVP-786. Avanir also announced 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. Full Article
Avanir Pharmaceuticals Inc Initiates Phase I Clinical Trial Of AVP-786
Avanir Pharmaceuticals Inc announced that it has initiated the first-in-human Phase I clinical trial of AVP-786 (formerly known as deuterated dextromethorphan). The trial is designed to assess the single and multiple dose pharmacokinetics, safety and tolerability of AVP-786 administered to healthy subjects. Approximately 40 subjects will be enrolled in this randomized crossover study to compare multiple dose levels of AVP-786 (alone and in combination with quinidine) with dextromethorphan/quinidine. The pharmacokinetic study of AVP-786 is expected to be completed in the first calendar quarter of 2013. The incorporation of deuterium into specific molecular positions of dextromethorphan, resulting in AVP-786, maintains the pharmacology of dextromethorphan and provides significantly enhanced resistance to CYP2D6 metabolism and improved plasma exposure in preclinical testing. Full Article
Avanir Pharmaceuticals Inc Announces Notice Of Allowance Of U.S. Patent Application Covering NUEDEXTA
Avanir Pharmaceuticals Inc announced that the United States Patent and Trademark Office (USPTO) has allowed a new patent that covers Avanir's product NUEDEXTA, further expanding the intellectual property portfolio for the Company's lead commercial asset. This asset is a dual sigma-1 and NMDA receptor modulator that is approved for the treatment of pseudobulbar affect (PBA), and is in clinical development for central neuropathic pain in patients with multiple sclerosis and agitation in patients with Alzheimer's disease. U.S. Patent application number 13/415,067, entitled Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders, claims methods for treating pseudobulbar affect or emotional lability using low-dose quinidine formulations of NUEDEXTA. The new patent will expire on July 17, 2023. In addition to this newly allowed patent, the Company has exclusive worldwide rights to a family of patents and patent applications that claim methods of treating various neurologic and psychiatric conditions using low-dose quinidine formulations of NUEDEXTA. Full Article
Avanir Pharmaceuticals Inc Announces FDA Acceptance Of IND For AVP-923 For Treatment Of Agitation In Patients With Alzheimer's Disease
Avanir Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease (AD). The Company plans to initiate a Phase II study evaluating AVP-923 during the third calendar quarter of 2012. The objectives of this proof of concept study are to evaluate the safety, tolerability, and efficacy of AVP-923 for treatment of agitation and other behavioral disturbances in Alzheimer's patients. The trial is a multicenter, randomized, double-blind, placebo-controlled study that is expected to enroll approximately 200 Alzheimer's patients in the United States. Eligible patients will be randomized to receive either AVP-923 or placebo for 10 weeks. The main efficacy measure is the Neuropsychiatric Inventory scale or NPI. Secondary outcome measures include measures of disease severity, cognition, activities of daily living, quality of life and caregiver strain. Standard safety assessments will also be conducted. Full Article
Avanir Pharmaceuticals Inc Announces $30 million Term Loan Agreement
Avanir Pharmaceuticals Inc announced that on May 7, 2012 the Company secured a $30 million term loan from Oxford Finance and Silicon Valley Bank. Under the loan agreement, Avanir will repay interest only on a monthly basis through June 2013, or upon meeting certain conditions, through January 2014, and thereafter Avanir will repay the principal and interest on a monthly basis through the maturity date of December 31, 2015. The interest rate for borrowings under the Loan Agreement will be fixed upon drawdown at a rate per annum equal to the greater of (i) 8.95% or (ii) the sum of (a) 8.38% and (b) the three month LIBOR rate. The loan is secured by a first priority security interest in all of the Company's assets, other than its intellectual property and its rights under license agreements granting it rights to intellectual property. The loan is expected to fund on or around June 1, 2012. In connection with entering into the loan agreement, the Company issued to the lenders warrants to purchase shares of the Company's common stock equal to 4.55% of the of the term loan at a price per share equal to the lower of the 10-day average share price prior to closing or the price per share on the day of closing. Full Article
Avanir Pharmaceuticals Announces Publication Of Phase III Study Results Showing Efficacy And Safety Of AVP-923 In Treatment Of Diabetic Neuropathic Pain
Avanir Pharmaceuticals announced that the results of the study entitled Efficacy and Safety of Dextromethorphan/Quinidine (AVP-923) at Two Dosage Levels for Diabetic Neuropathic Pain A Double-Blind, Placebo-Controlled, Multicenter Study. In a 13-week, phase III, randomized, controlled trial, 379 adults with daily symmetric diabetic peripheral neuropathy (DPN) leg pain for >3 months received double-blind placebo, DMQ 45/30 mg, or DMQ 30/30 mg, administered once daily for 7 days and twice daily thereafter. Efficacy measures included four pain rating scales applied daily using patient diaries, and another two applied at five clinic visits. Safety and tolerability were assessed by adverse event reports, physical examination, electrocardiogram and clinical laboratory tests. Patients with certain cardiac conditions were excluded from the study along with patients taking certain medications. On all six scales, DMQ 45/30 mg was significantly superior to placebo, including the primary efficacy analysis, which utilized mixed-effects modeling to test all scores on an 11-point numerical Pain Rating Scale (p < 0.0001). Sensitivity analyses gave consistent results. Efficacy versus placebo was also seen for diary ratings of present pain intensity, and pain interference with sleep and with activities (all p < 0.0001). Among clinic-visit assessments, DMQ 45/30 mg demonstrated greater leg-pain relief (p = 0.0002) and greater reduction of leg-pain intensity (p = 0.0286) versus placebo. Full Article
Avanir Pharmaceuticals Announces EMA Acceptance Of Marketing Authorization Application For NUEDEXTA
Avanir Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for NUEDEXTA (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA). Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review. The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA, plus data from the Company's longer-term safety studies. The MAA acceptance triggers the initiation of EMA's scientific assessment and opinion review period. Full Article
Avanir Pharmaceuticals Files Lawsuits Against Par Pharmaceutical Companies, Inc. And Actavis, Inc. For Infringement Of NUEDEXTA Patents
Avanir Pharmaceuticals announced that it has filed lawsuits in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc (collectively Par) and Actavis South Atlantic LLC and Actavis, Inc. (collectively Actavis). The lawsuits were filed in response to Abbreviated New Drug Applications (ANDAs) filed by Par and Actavis. In their applications, Par and Actavis seek to market and sell generic versions of the currently approved dose of NUEDEXTA prior to the expiration of U.S. patents 7,659,282 and RE38,115 (which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)). Avanir filed the lawsuits on the basis that Par's and Actavis' proposed generic products infringe certain patents held by Avanir. Full Article
Avanir Pharmaceuticals Provides Update On European Regulatory Filing For NUEDEXTA
Avanir Pharmaceuticals announced several positive developments regarding its anticipated European regulatory filing of NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules for the treatment of pseudobulbar affect (PBA). Earlier company officials met with the European Medicines Agency (EMA) to discuss plans for filing a marketing authorization application (MAA) for NUEDEXTA for the treatment of PBA. Based on the outcome of the meeting, the Company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA. The timing of the Company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan (PIP) for NUEDEXTA which may occur before the end of calendar year 2011. Full Article
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