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:7/29/2015)... , July 29, 2015  Depomed, Inc. (NASDAQ: ... that its Board of Directors, after careful consideration ... and legal advisors, has unanimously rejected the purported ... Horizon Pharma plc (NASDAQ: HZNP ) ("Horizon") ... Depomed in an all-stock transaction (the "July 21 ...
(Date:7/29/2015)... , 29 luglio 2015 Uno studio ... che l,ingestione quotidiana del probiotico L. reuteri ... e modifica la produzione intestinale di fattori proteici ... la somministrazione quotidiana di ceppo di L. ... compresse utilizzando il sistema di somministrazione brevettato BIO- ...
(Date:7/29/2015)... 29, 2015   KaloBios Pharmaceuticals, Inc . (Nasdaq: ... developing innovative therapies to benefit patients with diseases of ... today that the U.S. Food and Drug Administration (FDA) ... for KB003, an anti-GM-CSF monoclonal antibody (mAb), in patients ... is now active. The acceptance of this ...
Breaking Medicine Technology:Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 2Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 3Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 4Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 5Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 6Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 7Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 8Depomed's Board of Directors Unanimously Rejects Purported Revised, Highly Conditional, Unsolicited Proposal from Horizon Pharma plc 9È stato clinicamente dimostrato che il probiotico L. reuteri di Nutraceutix regola il metabolismo insulinico intestinale 2KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia 2KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia 3KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia 4KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia 5
... Growing... -- DUNDEE, Scotland, November 15, 2010 ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... s = ,; var first_result; // Results are keyed by longUrl, so we need to grab the first one. ...
... 2010 Roche (SIX: RO, ROG; OTCQX: RHHBY) and ... announced today that in the PROTECT ( Pr o-BNP ... Chronic HF T herapy) trial, a strategy ... with a significant reduction in total cardiovascular events, the ...
Cached Medicine Technology:Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 2Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 3Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 4Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 5Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 6Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 7Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 8Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 9Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 10Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 11Axis-Shield Acknowledges World Diabetes Day and Provides an Update on its Growing Diabetes Franchise in Emerging Markets 12NT-proBNP Guided Therapy Keeps Heart Failure Patients out of the Hospital Through a Reduction in Cardiovascular Events 2NT-proBNP Guided Therapy Keeps Heart Failure Patients out of the Hospital Through a Reduction in Cardiovascular Events 3
(Date:7/29/2015)... ... 2015 , ... Avatar Solutions has received official approval from CMS to administer ... CAHPS for PQRS Survey collects information about patients’ experiences of care within ... participate or they will receive a 2% penalty in 2017. At this point in ...
(Date:7/29/2015)... ... July 29, 2015 , ... This past week, CARE Surrogacy Center Mexico ... treasured member of the CARE extended family. , By shedding light on positive ... across the globe gain a newfound perspective on surrogacy in Mexico. The center wholeheartedly ...
(Date:7/29/2015)... ... July 29, 2015 , ... Andrzej Klos, M.D., has been reviewed and ... for nearly 38 years, is motivated each and every day by his sincere desire ... shine alongside his many awards and accolades, which include multiple listings in many highly ...
(Date:7/29/2015)... ... 2015 , ... Potomac Pilates, an elite Washington, D.C. metro area-based Pilates studio, ... ® by Potomac Pilates. On Thursday, July 30, Potomac Pilates will unveil its ... Potomac Pilates will continue to offer the same classes and personal experiences their clients ...
(Date:7/29/2015)... ... , ... Ticket Down is a reliable source of authentic tickets for the ... , The international soccer schedule of matches played on American soil continues to grow ... of the world’s greatest teams, Brazil, will travel to North America to compete with ...
Breaking Medicine News(10 mins):Health News:Avatar Solutions Approved to Administer CAHPS for Physician Quality Reporting System (PQRS) 2Health News:Avatar Solutions Approved to Administer CAHPS for Physician Quality Reporting System (PQRS) 3Health News:Heartfelt Interview Shows Extraordinary Impact of CARE Surrogacy Center Mexico 2Health News:Heartfelt Interview Shows Extraordinary Impact of CARE Surrogacy Center Mexico 3Health News:NJ Top Docs Presents, Dr. Andrzej Klos of Carepoint Health Pediatrics! 2Health News:NJ Top Docs Presents, Dr. Andrzej Klos of Carepoint Health Pediatrics! 3Health News:Same Great Pilates Studio, New Brand - Rock the Reformer 2Health News:Cheap USA vs. Brazil Tickets at Gillette Stadium: Ticket Down Cuts Presale Ticket Prices for Brazil vs. USA Men's National Soccer Team (USMNT) at Gillette Stadium 2Health News:Cheap USA vs. Brazil Tickets at Gillette Stadium: Ticket Down Cuts Presale Ticket Prices for Brazil vs. USA Men's National Soccer Team (USMNT) at Gillette Stadium 3
... seem like unlikely heroes in the battle against drug abuse, but ... dozens of human disease could claim that role. Scientists are ... more convenient animal model for studying the effects of cocaine and ... in ACS Chemical Neuroscience , a new monthly journal. ...
... high cholesterol and become obese? The same way as people ... fats. More importantly, according to two new studies led ... the same molecular mechanisms as humans to help maintain proper ... that contributes to obesity. The findings mean that as researchers ...
... ... Awards in October. , ... Raton, Fla. (PRWEB) December 2, 2009 -- ILS Technology, LLC, an industry leader in enabling ... recognized with awards for technical innovation to the industry., , , , ,On October 7th ...
... Holly Potter, vice president, Public Relations, National Media and Stakeholder ... at PR News, PR People luncheon held at ... PR People Awards competition showcases the top innovators and ... matter in the marketplace. The winners of this year,s program ...
... , SAN DIEGO, Dec. 2 US ... Nursery and Wellness products, is pleased to announce it will ... Oakland, Calif., at the Oakland Zoo on December 11-20, 2009. ... Department at 877-90-FARMS or visit http://cookswareafaire.com , Victor ...
... , ... Create Change campaign , WASHINGTON, Dec. 2 The ... year to help fund American Red Cross disaster response. ... $350,000, was given to help Philippine communities affected by typhoons ...
Cached Medicine News:Health News:Latest epidemic? High cholesterol, obesity in fruit flies 2Health News:Latest epidemic? High cholesterol, obesity in fruit flies 3Health News:ILS Technology and Customer ASML Recipients of Industry Recognition Awards 2Health News:Kaiser Permanente Public Relations Leader Wins PR People Award 2Health News:Kaiser Permanente Public Relations Leader Wins PR People Award 3Health News:US Farms, Inc. Showcasing Aloe365(TM) Product Line at Cook'sware A'faire at Oakland Zoo 2Health News:Hewlett-Packard Company Foundation Donates $1 Million for Red Cross Disaster Response 2Health News:Hewlett-Packard Company Foundation Donates $1 Million for Red Cross Disaster Response 3
This modular benchtop fume hood ventilates and purifies chemical fumes, allowing safe indoor release of exhaust. Bonded charcoal filters remove most organic contaminants. Options include final HEPA f...
... The spot fume hood mounts on ... 25cm x 12.7mm (10" x 1/2" ) ... open cone is placed above the source ... (1/2") I.D. tubing which connects to an ...
... exhaust hoods are designed to rest on ... a stream of air across the top ... Other sizes and types of hoods such ... available on special order in materials such ...
... Hood is an economical unit designed for ... number of fume hoods are needed. Excellent ... universities. Features include a one-piece shell molded ... corners for easy cleaning. A clear acrylic ...
Medicine Products: