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 compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing clinical trials including agitation in Alzheimer's disease, neuropathic pain in Multiple Sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral symptoms of autism. AVP-923 for the above investigational uses has not been approved by the FDA.

About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.

AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.

Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, including the risks and uncertainties associated with meeting the objectives of the study of AVP-786, including, but not limited to, risks relating to the successful development of this investigational drug, delays or failures in enrollment, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Avanir Investor & Media Contact
Ian Clements , PhD
ir@avanir.com 
+1 (949) 389-6700


'/>"/>
SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

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:8/2/2017)... AURORA, Ore. , Aug. 2, 2017  Life Flight ... Call Agreement. The agreement improves patient care and operational efficiency ... Springfield , Cottage Grove ... ICU level medical transportation. PeaceHealth and Life Flight Network work ... care available during transport, or when a time sensitive emergency ...
(Date:8/1/2017)... , Aug. 1, 2017   CerSci Therapeutics ... Dallas, Texas , has received notice from ... National Institutes of Health (NIH) that it has been ... grant totaling over $650,000 in 2017 with an additional ... CerSci,s Investigational New Drug application of their lead non-opioid ...
(Date:7/31/2017)... Tru-D SmartUVC robots have arrived at Brian Allgood Army Community ... for "Total Room Ultraviolet Disinfection," is a 5-foot-5 germ-killing robot that is ... cleans the area with traditional cleaning protocols. ... Tru-D fights germs at Army hospitals ... "Although the BAACH has a very low infection rate, below national ...
Breaking Medicine Technology:
(Date:8/20/2017)... MD (PRWEB) , ... August 20, 2017 , ... State ... one of 40 national causes up for a $25,000 grant. If the initiative wins, ... girl bullying – will expand into the Tri-County area of St. Mary’s, Calvert and ...
(Date:8/19/2017)... (PRWEB) , ... August 18, 2017 , ... ... partnership aimed at creating a transparent, verifiable database to help the cannabis industry ... ledger technology, Paragon hopes to deliver a faster technology with lower fees. Paragon ...
(Date:8/19/2017)... ... August 19, 2017 , ... Praeclarus Press has ... These illustrations show the diversity of the breastfeeding mothers, using bright colors ... of sizes. These illustrations are also available on tote bags, notepads, smartphone cases, ...
(Date:8/19/2017)... ... , ... “Congratulations! It's A Boy! God’s Gift: A Story of Love”: a ... “Congratulations! It's A Boy! God’s Gift: A Story of Love” is the creation of ... , Published by Christian Faith Publishing, Dale Anthony and Rachael Anthony’s new book is ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... highly specialized asset-light logistics provider of complex transport solutions for mission-critical and ... purchase Unitrans International Corporation, a division of Roadrunner Transportation Systems, Inc. (NYSE: ...
Breaking Medicine News(10 mins):