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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by ed_uk on November 1, 2006, at 14:16:01
US FDA issues “approvable” letter for tipataflam (Zenvia) for involuntary emotional expression disorder
According to a report by BioSpace, Avanir Pharmaceuticals has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for tipataflam (Zenvia®) for the treatment of involuntary emotional expression disorder (IEED) in patients with neurological diseases and brain injuries.
According to the report, the FDA has issued an approvable letter, but has requested additional safety and efficacy data.
Posted by ed_uk on November 1, 2006, at 15:00:49
In reply to US FDA issues “approvable” letter for tipataflam, posted by ed_uk on November 1, 2006, at 14:16:01
Sorry, I just did a 'cut and paste'. I have no idea where the word 'tipataflam' came from! Zenvia is (apparantly) the name name for Neurodex - a low dose combination of dextromethorphan (as in Robitussin) and quinidine (the antiarrhythmic).
From Medscape...........
A dextromethorphan-quinidine cocktail (Neurodex) effectively addresses the inappropriate laughing and crying episodes experienced by some patients with multiple sclerosis (MS), according to investigators who presented their findings here at the 57th annual meeting of the American Academy of Neurology.
The incongruous laughing and crying episodes, also called "emotional incontinence," are due to pseudobulbar affect (PBA). Dextromethorphan, the active ingredient in most over-the-counter cough suppressant syrups, also binds to the sigma-1 and N-methyl-D-aspartate neuroreceptors and therefore had the potential to address PBA.
"If we gave patients a sufficient dose of dextromethorphan alone to penetrate the central nervous system, the trade-off would be nausea and vomiting," principal investigator Hillel Panitch, MD, said during a press briefing. "However, because quinidine prevents systemic metabolism of dextromethorphan, we can use less dextromethorphan that is yet sufficient to address PBA." Dr. Panitch is a professor of neurology at the University of Vermont College of Medicine in Burlington, where he is the director of the Multiple Sclerosis Center at Fletcher Allen Health Care.
The investigative formulation, also known as AVP-923, consists of 30 mg each of dextromethorphan and quinidine sulfate. In a double-blind, placebo-controlled study, the investigators recruited 150 patients with MS at 22 community and university-based centers to be treated either with the study drug or placebo every 12 hours for 12 weeks. The patients completed a diary and recorded the number of episodes of inappropriate laughing, crying, or both that occurred each day and indicated the medications they took, the times they took them, and any adverse events. The patients had scored at least 13 on a validated self-assessment tool used to evaluate PBA.
The investigators saw the patients in follow-up clinic visits on days 15, 29, 57, and 85. At those times, they obtained patients' clinical chemistry, vital signs, physical examinations, and electrocardiograms. The investigators compared the change in self-assessment score between the treated and placebo patients and also assessed individual change from baseline to the date of each study visit. They also compared the number of laughing and crying episodes and used separate visual analog scale scores for overall quality of life, quality of relationships, and pain intensity.
Treated patients had a clinically and statistically greater reduction in their self-assessment scores than did those who received the placebo (P < .0001). Treated patients also had fewer laughing and crying episodes (P = .0002), a higher quality of life and relationships (P < .0001 and P = .0001, respectively), and less pain (P = .027).
When the investigators evaluated response rates, they found that 84% of treated subjects responded to treatment compared with 49% of placebo patients (P < .0010). The number of emotionally inappropriate episodes per week was 46% lower in the treated group than in the placebo group, with treatment effects observed the first week of treatment.
The rate and severity of adverse events were similar in the two groups, although more patients in the treated group reported dizziness (P = .01). Eleven treated patients (14%) discontinued treatment due to adverse events, as did eight placebo patients (11%). The investigators documented no clinically significant changes in other safety measures.
"I treat many patients with MS and it's refreshing to see a new treatment strategy that appears to have a low rate of side effects," said Michael E. Batipps, MD, who commented on the presentationin an interview seeking outside comment. "We've seen many drugs developed for MS that eventually have been found to have substantial side effects. PBA is a concerning development that we would like to prevent from happening, and the potential to treat it is encouraging. However, although the dextromethorphan-quinidine combination appears to show promise in a subset of MS patients, we will need to see whether these results are confirmed in further studies." Dr. Batipps is a neurologist in private practice in Washington, D.C., with a focus in MS.
Posted by ed_uk on November 1, 2006, at 15:34:01
In reply to US FDA issues “approvable” letter for tipataflam, posted by ed_uk on November 1, 2006, at 14:16:01
How strange. The original article made it sound like tipataflam was the generic name for Neurodex (now called Zenvia). In fact, Tipataflam is a piece of French software intended to help children learn to read. Tipataflam is produced by a company called Zenvia........which, as it happens, is the new name for Neurodex (dextromethorphan + quinidine). Somebody must have googled Zenvia and come up with Tipataflam, assumed tipaflam was the generic name for Zenvia etc.
Confused?
Posted by ed_uk on November 1, 2006, at 15:35:48
In reply to US FDA issues “approvable” letter for tipataflam, posted by ed_uk on November 1, 2006, at 14:16:01
SAN DIEGO--(BUSINESS WIRE)--Oct 31, 2006 - AVANIR Pharmaceuticals (NASDAQ:AVNR) announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zenvia(TM) (formerly referred to as Neurodex(TM)) for the treatment of involuntary emotional expression disorder ("IEED"). The Company submitted a new drug application ("NDA") in January 2006, seeking to market Zenvia for the treatment of IEED in patients with neurologic diseases and brain injuries. The communication from the FDA indicates that AVANIR's application is approvable, subject to the FDA and AVANIR reaching agreement on what additional safety and efficacy data will be required.
Posted by ed_uk on November 1, 2006, at 15:57:05
In reply to Zenvia/Neurodex, posted by ed_uk on November 1, 2006, at 15:35:48
I have emailed the pharmacist who wrote the article I 'cut and pasted' to inform her of her error!
Posted by ed_uk on November 2, 2006, at 13:58:52
In reply to Re: Zenvia/Neurodex, posted by ed_uk on November 1, 2006, at 15:57:05
>I have emailed the pharmacist who wrote the article I 'cut and pasted' to inform her of her error!
She replied :)
'Thank you very much for your feedback and correction.'
Ed
Posted by linkadge on November 3, 2006, at 18:12:19
In reply to Re: Zenvia/Neurodex » ed_uk, posted by ed_uk on November 2, 2006, at 13:58:52
What an annoying name. Tipataflam. It sounds like some space age sythetic fibre.
"Hey, I like your shirt"
"Yeah, I just got it...100% Tipataflam !"Linkadge
Posted by yxibow on November 3, 2006, at 20:54:40
In reply to What a stupid name., posted by linkadge on November 3, 2006, at 18:12:19
> What an annoying name. Tipataflam. It sounds like some space age sythetic fibre.
>
> "Hey, I like your shirt"
> "Yeah, I just got it...100% Tipataflam !"
>
> LinkadgeWhat a strange patent for existing product, as well. Robitussin plus a quinine derivative, and patented. But you can patent anything these days.
As far as the disorder, who knows, maybe there's some evidence.
Posted by ed_uk on November 4, 2006, at 14:27:28
In reply to What a stupid name., posted by linkadge on November 3, 2006, at 18:12:19
LOL, at least you won't hear the name Tipataflam again. It's a French computer programme, there is no drug called tipataflam!
Ed
Posted by ed_uk on November 4, 2006, at 14:31:23
In reply to Re: What a stupid name. » linkadge, posted by yxibow on November 3, 2006, at 20:54:40
Hi Yxi!
I think most doctors would be uncomfortable prescribing anything containing the antiarrhythmic drug quinidine (an isomer of quinine). Quinidine is strongly proarrhythmic and has been associated with sudden cardiac death. Although the dose of quinidine is Zenvia is very small, it's still a worry. They really ought to have found a better CYP2D6 inhibitor to use than quinidine. The purpose of the quinidine is Zenvia is solely to prolong the duration of action of dextromethorphan by inhibiting its metabolism.
Regards
Ed
Posted by Ti Pataflam on February 27, 2007, at 10:50:55
In reply to Re: US FDA issues “approvable” letter for tipataflam, posted by ed_uk on November 1, 2006, at 15:34:01
Hello,
We are the creators of the TiPataflam software, french software, and we had a good laugh while reading your theories on the origin of the "TiPataflam" name.
If you want to discuss the subject further in detail, we can do that, but in no way is TiPataflam a cosmetic or a drug.
This is the end of the thread.
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