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New pseudobulbar affect (PBA) study, New Rochelle, NY |
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| drdªv€ |
| Posted: Oct 8 2007, 11:42 PM |
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Santa called me a HO... 3 times!
Group: Lead Administrators
Posts: 2879
Member No.: 140
Joined: 17-June 03
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AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial of Zenvia™ (dextromethorphan/quinidine (DM/Q)) for the treatment of patients with pseudobulbar affect (PBA). AVANIR trial 07-AVR-123 "A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients with Amyotrophic Lateral Sclerosis and Multiple Sclerosis" (otherwise known as the "STAR trial") is expected to begin enrolling patients by the end of 2007.
"We now have a clear path toward gaining regulatory approval for Zenvia in this important indication and continue on track to begin patient enrollment in this trial before 2007 calendar year end," said Randall Kaye, MD, Chief Medical Officer of AVANIR. "We have developed an alternative formulation of Zenvia with a lower dose of the quinidine component than the formulation used in earlier PBA studies. Based on our extensive PK/PD modeling, we expect that the new formulation of Zenvia will demonstrate acceptable safety and tolerability, while continuing to provide significant efficacy."
"The STAR trial represents an important milestone for greater than one million Americans thought to suffer from the debilitating episodes of PBA," said Jeffrey Cummings, MD, Executive Vice Chair of the Department of Neurology at the David Geffen School of Medicine at UCLA and lead investigator of the STAR trial. "With no currently approved treatment options available, the STAR trial is an essential step toward making Zenvia available to patients with PBA."
About the STAR Trial
The STAR trial (Safety, Tolerability And Efficacy Results of AVP-923 in PBA) will be a randomized, double-blind, placebo-controlled, multi-center international study that will enroll approximately 270 patients suffering from PBA secondary to either multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). The trial will compare active treatment with Zenvia 30/10 mg (DM/Q) and Zenvia 20/10 mg (DM/Q) to placebo during a three month double-blinded phase followed by a three-month open-label extension study.
The primary efficacy analysis will be based on the changes in crying/laughing episode rates recorded in the patient diary. PBA episode counts will be reported and analyzed as a rate expressed as episodes per day. The secondary endpoints include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score, 2) Neuropsychiatric Inventory Questionnaire (NPI-Q), 3) SF-36 Health Survey, 4) Beck Depression Inventory (BDI-II), and 5) Pain Rating Scale score (MS patients only).
Safety and tolerability of Zenvia will be determined by reporting adverse events; physical exam, vital signs, electrocardiogram, respiratory function tests, and clinical assessment of clinical laboratory variables.
About a Special Protocol Assessment
A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm.
About PBA
Pseudobulbar affect (PBA), also known as involuntary emotional expression disorder (IEED) and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact more than 1 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury. PBA episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a "short circuit" and triggering involuntary PBA episodes. PBA has been shown to impair the lives of patients in both social and occupational settings. There are currently no FDA approved treatments for PBA.
About Zenvia
Zenvia is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for the treatment of Zenvia in PBA. The Company is initiating a confirmatory Phase III study under a Special Protocol Assessment agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm. In April 2007 AVANIR announced successfully meeting all primary endpoints in the Phase III study of Zenvia in DPN pain. The Company is considering the future development plan for Zenvia in this indication and expects to provide an update on this program later this year.
About AVANIR
AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system (CNS), inflammation and infectious diseases. AVANIR's lead product candidate Zenvia is being developed for the treatment of pseudobulbar affect (PBA) and is the subject of an approvable letter from the FDA for that indication. Additionally, in April 2007 AVANIR announced meeting all primary endpoints in a Phase III clinical trial with Zenvia in patients with diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed a compound to Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. AVANIR's infectious disease drug candidate, AVP-21D9, is a human monoclonal antibody in pre-clinical development for the treatment of anthrax with funding provided to date from an NIH/NIAID grant. The Company's first commercialized product, Abreva®, is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
Forward Looking Statements
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. There can be no assurance that the proceeds received by the Company from the recent sale of the Company's FazaClo® operations, together with the Company's other available funds, will be sufficient to fund the Company's operations as currently anticipated, or that the Company will be able to commence and complete planned clinical trials within the projected time periods. There can also be no assurance that the planned Phase III trial for Zenvia will be successful, that the new dose of Zenvia will be safe and effective, or that the FDA will approve Zenvia for this or any other indication. Risks and uncertainties affecting the Company's financial condition and operations also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.
http://www.genengnews.com/news/bnitem.aspx...x?name=24372016
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Growing old is mandatory... growing up is optional. ;)
Know your body, Known your mind, Know your substance, Know your source
RIP RDT 12-27-65/6-04-06
Brother, Friend, Confidante & Co-Conspirator
"All of my heroes have now become ghosts"
"friends help you move... best friends help you move bodies." |
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| Kang |
| Posted: Oct 9 2007, 12:10 AM |
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I was Mike
Group: Members
Posts: 597
Member No.: 9491
Joined: 28-February 07
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Its only a matter of time before dex is no longer OTC, at least they finally found a legit medical use for it though.
This post has been edited by Kang on Oct 9 2007, 12:15 AM
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Everything is relevant.
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| infinite |
| Posted: Oct 9 2007, 03:09 AM |
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Plateau Sigma
Group: Members
Posts: 673
Member No.: 10764
Joined: 5-July 07
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heard it's being used to help people quit smoking as well dex ftw
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Be at peace with your mind for in the end it is all you will have
-Me
Just open your eyes
And see that life is beautiful.
Matter is NOT made up of matter.
God will send you to a place of fire and pain if you don't agree with him....but he LOVES YOU!!!
All powerful, all knowing, but he can't handle money, either!! |
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| Eloivore |
| Posted: Oct 10 2007, 09:16 AM |
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There is a subtle beauty in the thing
Group: Lead Administrators
Posts: 5134
Member No.: 3545
Joined: 23-September 04
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| QUOTE | | Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. |
Someday I want to hear someone put that in their marriage vows.
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"... the feverish delusions and utter helplessness is learned and best not overdone. quit sucking on the teat of dr mom" - libel
"When the Man finally comes knocking on your door, it doesn't matter whose grandparents wore the funniest hats on Sunday." - Telkandore
"the shittiest part about the internet is that we can mix baby taunts with heavier concepts, top it off with graphic imagery, and go home feeling like we just did something smart." - d8ff752 |
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| Cross The Rubicon |
| Posted: Oct 10 2007, 02:07 PM |
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Dextroverse Regular
Group: Members
Posts: 771
Member No.: 2377
Joined: 18-May 04
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as above poster said,, i would give props by names if i wasnt so dexed, and sitting here in the library, and to lazy to scroll down a page...
its great that they have actually found what might be a legit medical use for dxm :D
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Rinse out the ugly and purge every demon
A small step for progress a leap for the mind
The smoke never settles where everything’s even
A poke in the eye the equation is nil |
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| AFireInside |
| Posted: Oct 10 2007, 03:40 PM |
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First Plateau
Group: Members
Posts: 108
Member No.: 10247
Joined: 13-May 07
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Can't wait to chug this stuff...
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You can feel the waves coming on. (It's time to take the time) Let them destroy you or carry you on. (It's time to take the time) You're fighting the weight of the world, but no one can save you this
time. Close your eyes. You can find all you need in your mind.
Take the Time by Dream Theater ("Each member of the band wrote a section of the lyrics. The lyrics reflect their feelings about the long, frustrating period of the band's early history during which they were searching for a new vocalist.")
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| jonscotch |
| Posted: Oct 10 2007, 05:16 PM |
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Member
Group: Members
Posts: 65
Member No.: 11068
Joined: 9-August 07
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Can someone put this into layman terms for us dummys? |
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| AFireInside |
| Posted: Oct 10 2007, 08:29 PM |
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First Plateau
Group: Members
Posts: 108
Member No.: 10247
Joined: 13-May 07
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| QUOTE (jonscotch @ Oct 10 2007, 05:16 PM) | | Can someone put this into layman terms for us dummys? |
This is DXM syrup with stuff in it that makes the DXM more potent without increasing the dosage? I think the added stuff in this syrup is sort of like GFJ.
"Compounds in the juice including bergamottin, dihydroxybergamottin, and some flavonoids such as naringin effect the activity of certain intestinal enzymes including CYP3A4 and CYP1A2."
Yupppp... Basically this is going to be super dex syrup. Pray they're tablets. =D
Well, actually I don't know... "Quinidine is also an inhibitor of the cytochrome P450 enzyme 2D6, and can lead to increased blood levels of lidocaine, Beta blockers, opioids, and some anti-depressants."
Who wants to confirm any of this jargled non sense? =D
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You can feel the waves coming on. (It's time to take the time) Let them destroy you or carry you on. (It's time to take the time) You're fighting the weight of the world, but no one can save you this
time. Close your eyes. You can find all you need in your mind.
Take the Time by Dream Theater ("Each member of the band wrote a section of the lyrics. The lyrics reflect their feelings about the long, frustrating period of the band's early history during which they were searching for a new vocalist.")
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| drdªv€ |
| Posted: Oct 11 2007, 05:10 AM |
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Santa called me a HO... 3 times!
Group: Lead Administrators
Posts: 2879
Member No.: 140
Joined: 17-June 03
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| QUOTE | Avanir gets special protocol assessment for Zenvia
10th October 2007
Avanir Pharmaceuticals has reached a definitive agreement with the FDA, under the special protocol assessment process, on the design of a Phase III clinical trial of Zenvia for the treatment of patients with pseudobulbar affect.
The trial, which is aimed at determining the pharmacokinetics of two doses of Zenvia (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA) in patients with amyotrophic lateral sclerosis and multiple sclerosis (also know as Star trial) is expected to begin enrolling patients by the end of 2007.
Pseudobulbar affect, also known as involuntary emotional expression disorder and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays.
Randall Kaye, chief medical officer, said: "We now have a clear path toward gaining regulatory approval for Zenvia in this important indication and continue on track to begin patient enrollment in this trial before 2007 calendar year end. We have developed an alternative formulation of Zenvia with a lower dose of the quinidine component than the formulation used in earlier PBA studies.
"Based on our extensive PK/PD modeling, we expect that the new formulation of Zenvia will demonstrate acceptable safety and tolerability, while continuing to provide significant efficacy." |
http://www.pharmaceutical-business-review....83-B6A76C81D37D
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Growing old is mandatory... growing up is optional. ;)
Know your body, Known your mind, Know your substance, Know your source
RIP RDT 12-27-65/6-04-06
Brother, Friend, Confidante & Co-Conspirator
"All of my heroes have now become ghosts"
"friends help you move... best friends help you move bodies." |
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