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Dr. Bob is Robert Hsiung, MD,
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Posted by Tomatheus on September 17, 2015, at 17:06:52
Press release: FDA approves Vraylar for schizophrenia, bipolar
The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
"Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs."
Schizophrenia is a chronic, severe and disabling brain disorder affecting about 1 percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices or seeing things that are not there, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high, irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.
The efficacy of Vraylar in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Vraylar was shown to reduce the symptoms of schizophrenia compared to placebo.
The efficacy of Vraylar in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Vraylar was shown to reduce symptoms of bipolar disorder in each of the trials.
Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis. Neither Vraylar nor any other drug in this class is approved to treat such patients.
The most common side effects reported by participants receiving Vraylar in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements. The most common side effects reported by trial participants receiving Vraylar for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.
Vraylar is manufactured by Forest Laboratories LLC of Jersey City, N.J., and the medication is distributed by Actavis Pharma Inc. of Parsippany, N.J.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
==
Source: U.S. Food and Drug Administration
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463103.htm
Posted by Phillipa on September 17, 2015, at 17:42:28
In reply to FDA approves Vraylar for schizophrenia, bipolar, posted by Tomatheus on September 17, 2015, at 17:06:52
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Dr. Julie Atwood| Psychiatry/Mental Health 20 minutes ago
No drug in this class has yet to be free of serious metabolic effects, particularly in bipolar patients, so I will be very cautious with this drug until a more thorough examination is available.FlagLikeReply
Dr. T H| Psychiatry/Mental Health 1 hour ago
Interesting. Cariprazine "decreased symptoms" of schizophrenia and bipolar disorder compared to placebo, Side effects are mostly EPS, Early development of EPS is a warning sign of possible TD later on.Unless the reduction of symptoms is substantial and the drug is not too expensive, what would be the rationale to use it when we have drugs with lot less side effects?Flag1LikeReply
Dr. Charles Bensonhaver| Psychiatry/Mental Health 1 hour ago
We already have a wide spectrum of agents efficacious in Schizophrenia and Bipolar Disorder. What value added does this have? I am sure it is not cheap, so there needs to be a very good reason to prescribe it.Flag1LikeReply
Dr. Sukhjit Brar| Psychiatry/Mental Health 1 hour ago
I don't see any mention about metabolic side effects and any effect on qtc interval. The positive thing is that patients have more options to choose from.FlagLikeReply
Dr. Bob Gale| Psychiatry/Mental Health 1 hour ago
There is no such thing as a "side" effect when a chemical is added to a person (who is essentially a machine made and run by and with chemicals). There are only good "positive," adverse "bad" (either or both with variable type and intensity, and no effects. The term "side effect," created by pharma, insurance, medical providers, and their lawyers, was invented and then used to prevent/diminish lawsuits and increase patient awareness, expectation, acceptance, and fear, increase sales and allow for frequently deceptive advertising. It is inherently a dishonest term and also obfuscates the very real differences among people's type and degree of reaction to ingesting a "foreign" chemical, including the relatively unique responses as well as the 20-40% that don't respond well, but don't prevent FDA approval. Bob Gale, MD, JDFlag1LikeReply
Dr. Rangaesh Gadasalli| Internal Medicine 2 hours ago
As many serious side effects have been reported with in a short period of six weeks,that also includes death in seniors with dementia, CAUTION should be exercised by all Health care providers in prescribing this new drug. One good thing is , that we have many good drugs to treat Schizophrenia now. Olanzapine, Zipra sidone, Risperidone and Seroqul have been in the market for more than a decade and millions of patients have benefited from these Medications. what is needed is careful regular monitoring of patients for hematological issues-(leucopenia,) and weight gain is important.
Posted by Tomatheus on September 17, 2015, at 18:16:04
In reply to Re: Medscape 6 phyciatrists comments, posted by Phillipa on September 17, 2015, at 17:42:28
Thank you for posting those comments, Phillipa. With regard to what advantages Vraylar (cariprazine) might have over other related medications, there is some evidence from a Phase III study that cariprazine significantly outperformed risperidone as far as the treatment of the negative symptoms of schizophrenia was concerned. See this article for more information:
So, cariprazine might be a promising medication for patients with schizophrenia with a history of negative symptoms, especially for patients whose negative symptoms haven't responded favorably to other treatments. It might also turn out to be a useful medication for other patient populations. Cariprazine might, for instance, represent a helpful option for patients (even those without "negative" psychotic symptoms) who've tried other medications and therapies with little to no success.
Having said what I've said, I do think that the psychiatrists that you quoted made some very good points.
Tomatheus
Posted by Phillipa on September 17, 2015, at 20:02:00
In reply to Re: Medscape 6 phyciatrists comments » Phillipa, posted by Tomatheus on September 17, 2015, at 18:16:04
First time I ever posted the comments. Just recently realized that comments at bottom to click on to. P
Posted by SLS on September 17, 2015, at 20:14:08
In reply to FDA approves Vraylar for schizophrenia, bipolar, posted by Tomatheus on September 17, 2015, at 17:06:52
Vraylar (cariprazine) is currently in phase III trials for bipolar depression. The results have been encouraging. Pharmacologically, the drug is more like Abilify than Risperdal. I am hoping that cariprazine is more effective to treat the negative symptoms shizophrenia and the anhedonia and amotivation of depression.
Like Abilify, Vraylar will probably be more likely to produce akathisia than are most other atypical antipsychotics. However, it might be less likely to produce movement EPS.
- Scott
Posted by Tomatheus on September 18, 2015, at 0:45:25
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by SLS on September 17, 2015, at 20:14:08
Thank you for your post, Scott. I too hope that patients taking cariprazine will find the medication to be effective for the negative symptoms of schizophrenia and for certain depressive symptoms. Are you considering trying it, Scott? I might ask my psychiatrist about it if I come across enough anecdotal reports of it helping with concentration, energy, and/or overall cognition.
Tomatheus
Posted by Lamdage22 on September 18, 2015, at 2:18:19
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar » SLS, posted by Tomatheus on September 18, 2015, at 0:45:25
unfortunately i am prone to nasty akathisia.
Posted by Christ_empowered on September 18, 2015, at 12:35:28
In reply to FDA approves Vraylar for schizophrenia, bipolar, posted by Tomatheus on September 17, 2015, at 17:06:52
akathisia is rough, but I'm more concerned about movement disorders...why bring a drug to market if the TD risk is not much better than older drugs, or perhaps even worse than other "atypicals" ? That's not really progress.
That said...I got akathisia from Zyprexa, but not Abilify. Normal dopamine blockers--even the atypical ones--were/are problematic, but Abilify doesn't cause near as many problems.
So...there could be a subset of patients who need an AP and this could be just the thing for them, just like w/ Abilify some people who can't tolerate other drugs can tolerate Abilify.
I dunno. On the one hand, its good to have new drugs added, especially if they have at least somewhat unique mechanisms of action. On the other hand...Rx drugs are so weird. Its not a free market. You get what your doc prescribes and then somebody has to pay for it, somehow. So patients who might benefit may not get the Rx, patients who might want/need something else will get the Rx, and patients who need but can't afford it may have to stick w/ risperdal or something.
Ugh.
Posted by Tomatheus on September 18, 2015, at 15:32:11
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Lamdage22 on September 18, 2015, at 2:18:19
> unfortunately i am prone to nasty akathisia.
Thanks for commenting here, Lamdage. I haven't looked at the study data for Vraylar (cariprazine), but with akathisia being the first side effect of the medication mentioned in the press release and with it being perhaps more pharmacologically similar to Abilify (aripiprazole) than it is to other atypical antipsychotics, I would definitely understand why you (being someone who's prone to akathisia) might want to avoid this medication. Having said this, if you're really curious, you might want to look into what the incidence of akathisia was on Vraylar and see how it compares with that of Abilify and other antipsychotics.
Tomatheus
Posted by Tomatheus on September 18, 2015, at 15:47:24
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Christ_empowered on September 18, 2015, at 12:35:28
> akathisia is rough, but I'm more concerned about movement disorders...why bring a drug to market if the TD risk is not much better than older drugs, or perhaps even worse than other "atypicals" ? That's not really progress.
>
> That said...I got akathisia from Zyprexa, but not Abilify. Normal dopamine blockers--even the atypical ones--were/are problematic, but Abilify doesn't cause near as many problems.
>
> So...there could be a subset of patients who need an AP and this could be just the thing for them, just like w/ Abilify some people who can't tolerate other drugs can tolerate Abilify.
>
> I dunno. On the one hand, its good to have new drugs added, especially if they have at least somewhat unique mechanisms of action. On the other hand...Rx drugs are so weird. Its not a free market. You get what your doc prescribes and then somebody has to pay for it, somehow. So patients who might benefit may not get the Rx, patients who might want/need something else will get the Rx, and patients who need but can't afford it may have to stick w/ risperdal or something.
>
> Ugh.Thank you for your comments here, Christ_empowered. I think that you made a number of excellent points, and yes, I think that the cost of this medication is likely to be an issue. I also hope that there were sufficient data available to give the public some degree of confidence that this medication will be safe and effective. The three-week trials that were mentioned in the press release somehow don't seem to be long enough to me.
Tomatheus
Posted by herpills on September 19, 2015, at 10:28:50
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar » Christ_empowered, posted by Tomatheus on September 18, 2015, at 15:47:24
The three-week trials that were mentioned in the press release somehow don't seem to be long enough to me.
>
> TomatheusI agree. Especially for bipolar. How could you possibly say after three weeks that it's effective for bipolar?
Posted by herpills on September 19, 2015, at 10:32:06
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Christ_empowered on September 18, 2015, at 12:35:28
Its not a free market. You get what your doc prescribes and then somebody has to pay for it, somehow. So patients who might benefit may not get the Rx, patients who might want/need something else will get the Rx, and patients who need but can't afford it may have to stick w/ risperdal or something.
>
> Ugh.Exactly. It's almost as if big pharma (corporations) make the laws that decide what medicines will be available and what medicines insurance (or medicaid) will cover. I'm pretty sure they'll spend millions fighting the legality of medical marijuana. God forbid we actually have choices.
Posted by Lamdage22 on September 20, 2015, at 4:14:19
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar » Christ_empowered, posted by herpills on September 19, 2015, at 10:32:06
there are no anecdotes whatsoever about cariprazine
Posted by SLS on September 20, 2015, at 5:53:37
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Lamdage22 on September 20, 2015, at 4:14:19
> there are no anecdotes whatsoever about cariprazine
None that have been made readily available, anyway.
Cariprazine acts like Abilify as a dopamine receptor partial agonist. However, it hits D3 receptors harder than D2 receptors when compared to Abilify. It is more selective for D3, and might have more antidepressant effects than Abilify. That is my hope, anyway. I don't know if there are any other advantages to cariprazine. It probably will cause weight gain and some degree of startup akathisia. I hope to find out soon.
Open label protocol:
"About this Phase III Study
This 97 week study was a multi-national, multi-center, randomized, double-blind, placebo-controlled clinical trial in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.In the double-blind phase, there were no cariprazine adverse events >/=10%. Across the cariprazine treated group, the most common adverse events (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and blood creatine phosphokinase increased."
- Scott
Posted by Tomatheus on September 20, 2015, at 13:51:31
In reply to FDA approves Vraylar - 97 week phase III study, posted by SLS on September 20, 2015, at 5:53:37
> > there are no anecdotes whatsoever about cariprazine
>
> None that have been made readily available, anyway.
>
> Cariprazine acts like Abilify as a dopamine receptor partial agonist. However, it hits D3 receptors harder than D2 receptors when compared to Abilify. It is more selective for D3, and might have more antidepressant effects than Abilify. That is my hope, anyway. I don't know if there are any other advantages to cariprazine. It probably will cause weight gain and some degree of startup akathisia. I hope to find out soon.
>
> Open label protocol:
>
> http://www.prnewswire.com/news-releases/richter-and-actavis-announce-positive-phase-iii-results-for-cariprazine-in-the-prevention-of-relapse-in-patients-with-schizophrenia-300022547.html
>
> "About this Phase III Study
> This 97 week study was a multi-national, multi-center, randomized, double-blind, placebo-controlled clinical trial in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.
>
> In the double-blind phase, there were no cariprazine adverse events >/=10%. Across the cariprazine treated group, the most common adverse events (incidence >/=5% and greater than placebo) were nasopharyngitis, tremor, extrapyramidal disorder, akathisia, back pain, and blood creatine phosphokinase increased."
>
>
> - ScottThank you for posting this information, Scott. Judging from the press release that I posted, it seemed that the only trials that had been conducted on Vraylar were three weeks in length. The study that you made reference to was obviously a lot longer, even though it included an open-label period, and even though patients were ultimately only randomly assigned to receive either Vraylar or placebo if they responded to the medication and met stability criteria after the open-label period. Despite the fact that some might criticize the design of this study, I think it's helpful to see that a lengthy Vraylar trial for schizophrenia was conducted. Do you know if any Vraylar trials exceeding three weeks were conducted for the treatment of bipolar disorder?
Tomatheus
Posted by Lamdage22 on September 20, 2015, at 13:57:33
In reply to Re: FDA approves Vraylar - 97 week phase III study » SLS, posted by Tomatheus on September 20, 2015, at 13:51:31
I am concerned about movement disorders.
Posted by Lamdage22 on September 20, 2015, at 14:04:43
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Lamdage22 on September 20, 2015, at 4:14:19
Does "approved by FDA" mean that it can be ordered through pharmacies already?
Or does it mean "available in a couple months".
I have never observed a med so early on.
I am particularly exited about Rapastinel (Glyx-13) and NRX-1074. I may try ahead of time.
Posted by Tomatheus on September 20, 2015, at 14:25:50
In reply to Re: FDA approves Vraylar for schizophrenia, bipolar, posted by Lamdage22 on September 20, 2015, at 14:04:43
Lamdage,
It's been my observation that medications tend to take a least a few weeks to become available in pharmacies after receiving FDA approval. So, although I don't know exactly when Vraylar might become available in pharmacies, I would probably give it at least a few weeks.
Tomatheus
Posted by SLS on September 20, 2015, at 14:52:26
In reply to Re: FDA approves Vraylar - 97 week phase III study » SLS, posted by Tomatheus on September 20, 2015, at 13:51:31
> Thank you for posting this information, Scott. Judging from the press release that I posted, it seemed that the only trials that had been conducted on Vraylar were three weeks in length.
The more recent short trials were only needed as supplements to the earlier long trials in order to more precisely determine dosage recommendations. Safety and efficacy had already been demonstrated.
- Scott
Posted by Lamdage22 on September 21, 2015, at 8:23:37
In reply to Re: FDA approves Vraylar - 97 week phase III study » Tomatheus, posted by SLS on September 20, 2015, at 14:52:26
Thanks Tomatheus.
This is the end of the thread.
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