Navigation Links
Avanir Pharmaceuticals Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting with FDA
Date:6/5/2013

ALISO VIEJO, Calif., June 5, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has agreed to an expedited development pathway for their next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application.  Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.

(Logo: http://photos.prnewswire.com/prnh/20130207/LA55901LOGO )

"We are very pleased with the outcome of our recent meeting with the Division of Neurology of the FDA," said Joao Siffert , MD, Avanir's chief scientific officer.  "Avanir will be allowed to reference the extensive data generated during AVP-923 development programs in support of the AVP-786 IND and subsequent new drug application. This has the potential to substantially reduce the cost and time to market.  We anticipate that we will be able to seamlessly integrate AVP-786 into our ongoing development programs in neuropathic pain, agitation in Alzheimer's disease and levodopa induced dyskinesia in Parkinson's disease."

About AVP-786
AVP-786 is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan (a new chemical entity or NCE) and ultra-low dose quinidine, used as a metabolic inhibitor. Incorporation of deuterium into specific positions of the dextromethorphan molecule strengthens the chemical bonds and reduces susceptibility to enzyme cleavage and first pass metabolism, but without altering its pharmacology. AVP-786 is an investigational drug not approved by the FDA.

About AVP-923
AVP-923 is a combination of two well-characterized
'/>"/>

SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Avanir Pharmaceuticals To Present at Three Conferences In May
2. Avanir Pharmaceuticals Announces Date Of Fiscal 2012 Second Quarter Financial Results And Conference Call
3. Avanir Pharmaceuticals to Present at Jefferies 2012 Global Healthcare Conference
4. Avanir Pharmaceuticals Announces Date Of Fiscal 2012 Third Quarter Financial Results And Conference Call
5. Avanir Pharmaceuticals To Present At Two Investor Conferences In August
6. Avanir Pharmaceuticals Announces Enrollment Of First Patient In Study Of AVP-923 For The Treatment Of Agitation In Patients With Alzheimers Disease
7. Avanir Pharmaceuticals Announces Publication Of PBA Burden Of Illness Study
8. Avanir Pharmaceuticals To Present At UBS Global Life Sciences Conference
9. Avanir Pharmaceuticals Achieves Commercial Milestones & Provides Clinical Updates
10. Avanir Pharmaceuticals To Present At 24th Annual Piper Jaffray Healthcare Conference
11. Avanir Pharmaceuticals Pre-Announces Preliminary Fiscal 2012 Fourth Quarter Results And Provides Clinical Study Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2015)... May 28, 2015  The recent flurry of ... and employer groups scrambling to identify a pharmacy ... managed care plan, retail pharmacy chain, or other ... billion purchase of Catamaran, Rite Aid,s $2 billion ... purchase Omni-Care for $10 billion are just the ...
(Date:5/28/2015)... 28, 2015 The Federal Trade Commission ... suit charging Cephalon, Inc. with illegally blocking generic ... settlement ensures that Teva Pharmaceutical Industries, Ltd., which ... of $1.2 billion available to compensate purchasers, including ... of Cephalon,s illegal conduct.  Some ...
(Date:5/28/2015)... Columbia , May 28, 2015 ... an intravenous catheter-based phrenic-nerve-pacing system announced today that ... Global Healthcare Conference on Thursday, June 4, 2015 ... present at 11:30 a.m. Eastern Time.   ... Medical is a preclinical stage medical device company ...
Breaking Medicine Technology:Citizens Rx Addresses Recent PBM Consolidation and Rising Pharmacy Costs 2Citizens Rx Addresses Recent PBM Consolidation and Rising Pharmacy Costs 3FTC Settlement of Cephalon Pay for Delay Case Ensures $1.2 Billion in Ill-Gotten Gains Relinquished; Refunds Will Go To Purchasers Affected By Anticompetitive Tactics 2FTC Settlement of Cephalon Pay for Delay Case Ensures $1.2 Billion in Ill-Gotten Gains Relinquished; Refunds Will Go To Purchasers Affected By Anticompetitive Tactics 3
... 1, 2011 Serina Therapeutics, Inc. President and CEO Randall ... a $9.5 million financing round to advance its lead oncology ... early 2012. "We are pleased to report to ... round that was launched in late 2010. This is a ...
... 2011 Endo Pharmaceuticals (Nasdaq: ENDP ) today ... officer will present a corporate overview at the Goldman Sachs ... p.m. PT.  The conference will be held at the Terranea ... webcast and audio archive of the presentation will be available ...
Cached Medicine Technology:Serina Therapeutics, Inc. Closes $9.5 Million Financing Round 2
(Date:5/28/2015)... Workers’ compensation costs per claim in Michigan were ... by the Workers Compensation Research Institute (WCRI) said, ... The WCRI study, CompScope™ Benchmarks for Michigan, 15th Edition, ... or more of work with those of 16 other states. ... was 4 percent lower than similar claims from 2008. That ...
(Date:5/28/2015)... Baptist Medical Center Jacksonville has added ... acute stroke or other neurological conditions. , The new ... few in the country and the first in Florida ... as brain aneurysms. , “Baptist Health is committed ... who are impacted by stroke,” said Nicole Thomas, Baptist ...
(Date:5/28/2015)... TX (PRWEB) May 28, 2015 Dr. ... cosmetic surgeons , has announced that the new Houston ... The American Association of Accreditation of Ambulatory Surgery Facilities ... surgery center . , According to Dr. Vitenas, ... meeting the standards of a Class C ambulatory surgery ...
(Date:5/28/2015)... 2015 Sexual Health Innovations, a ... sexual health and wellbeing in the United States, ... Francisco (USF) will be the first institution to ... and reporting system. , Callisto is designed ... reporting experience for college sexual assault survivors, to ...
(Date:5/28/2015)... A bucket list should include dreams, ... item on the bucket list can be tiny, small, ... that the owner wants to happen in their own ... it comes to making this list. Bucket list ... a book, seeing the Grand Canyon on horseback, skydiving, ...
Breaking Medicine News(10 mins):Health News:Michigan Workers’ Compensation Costs Lower Than Most States, Says WCRI Study 2Health News:Baptist Medical Center Jacksonville Adds Dedicated Neuro Emergency Unit 2Health News:Baptist Medical Center Jacksonville Adds Dedicated Neuro Emergency Unit 3Health News:Dr. Paul Vitenas’ New Houston Surgery Center Receives AAAASF Accreditation 2Health News:University of San Francisco Becomes First in the Nation to Adopt College Sexual Assault Reporting System 2Health News:University of San Francisco Becomes First in the Nation to Adopt College Sexual Assault Reporting System 3
... than smoking pot, snorting cocaine among 12-year-olds, study finds ... have used inhalants to get high than marijuana, ... , These potentially deadly inhalants include aerosol computer cleaners, ... or sniffed and can cause addiction or sudden death ...
... rotator cuff a warning sign, but exercise regimens can help, ... another baseball season nears, researchers report that preseason measurements of ... at high risk of developing a shoulder injury during play. ... if they are weaker, players are more likely to incur ...
... detection is key to more effective treatment for Alzheimer,s disease ... that a test developed at the University of Tennessee is ... with these diseases. The test, called CST -- for ... and relatively simple for medical professionals to administer and for ...
... babies born to mothers who had the flu while pregnant ... those observed in human patients with schizophrenia, a study at ... North Carolina at Chapel Hill has found. The study, ... the first study done with monkeys that examines the effects ...
... While there are many benefits of losing weight, weight ... weight loss, bones are being remodeled - breaking down old ... As a result, bone density is reduced, causing increased fragility. ... weight-bearing exercise, in this case, fast walking or jogging, did ...
... ... E-prescribing Company Depends on StrataScale’s Flagship Service for Reliable, Secure, Highly-scaleable Infrastructure Solution ... ... managed hosting solution, today announced that Dr. Dispense, a point of care medication ...
Cached Medicine News:Health News:Inhalant Abuse a Deadly Middle-School Concern 2Health News:Pre-Season Test Spots Baseball Pitchers at Risk of Injury 2Health News:Pre-Season Test Spots Baseball Pitchers at Risk of Injury 3Health News:New Alzheimer's test offers better opportunities for early detection 2Health News:Mother's flu during pregnancy may increase baby's risk of schizophrenia 2Health News:Weight-bearing exercise does not prevent increased bone turnover during weight loss 2Health News:Dr. Dispense Chooses World's First Fully Automated Managed Hosting Solution from StrataScale for All Outsourcing Needs 2Health News:Dr. Dispense Chooses World's First Fully Automated Managed Hosting Solution from StrataScale for All Outsourcing Needs 3
... Oscors proprietary quadripolar pacing wire ... pacing and sensing in the ... two bipolar wires in one ... the atrium and ventricle are ...
... T is a quadripolar pacing ... pacing and monitoring during and ... 227 T features tines for ... allows safe and easy implantation ...
For temporary cardiac pacing after open heart surgery. The zig-zag portion of the heartwire is embedded into the desired area of the myocardium (epicardially)....
For temporary cardiac pacing after open heart surgery. The zig-zag portion of the heartwire is embedded into the desired area of the myocardium (epicardially)....
Medicine Products: