Latuda: New Antipsychotic Drug Approved

[Lasso]

http://www.latuda.com/

Seems like we will get another choice in our treatments.

It does have alot of akathisia, unfortunately.

[notfred]

Commonly Observed Adverse Reactions (≥5%and at least twice that for placebo): The most commonly observedadverse reactions associated with the use of LATUDA versus placebo inshort-term clinical studies were somnolence, akathisia, nausea,parkinsonism, and agitation.

Seems like more of the same, side effect wise. Still there has got to be a few people who do really well on this med.

nf

[Kaashii]

More of the same, side effect-wise, but for those of us who are running out of options quickly, something else to try is good news! Although...with my weight and family history of diabeetus, I think she might say it's a no-go for me. Then again, I think the warning sheets for half the stuff I have been on have been just as bad or worse, so we'll see. (I just hope it's not a sublingual tablet like Saphris, YUCK!)

[netsavy006]

Based on what I read of it, it sounds like another atypical medication. Most of the stuff seemed to have been stuff I remember reading from other PI sheets from other medications (like Geodon or Abilify) when I was in my pre-occupations with meds and reading about them.

But I'm glad that a new medication is coming out for those who may need a new medication to try who are running out of options.

But me, I found the AAP that works for me (Clozaril) and I'm going to stick with it.

[Velvet Elvis]

Did you read the Additional Important Warnings? I think I'll be skipping this med.

That's a lower rate of EPS than risperdal IIRC.

[AnneMarie]

I wonder why they didn't seek bipolar approvals.

[dedoubt]

"Latuda"? Seriously, who comes up with these names? I can see it now-- "Latuda, gives ya a new attituda!"

Bleah.

[Kaashii]

Yeah, I thought the name was pretty bad too. At least it's not like Saphris, which sounds like some kind of STD to me. Latuda sounds more like it should be a name for a computer than a medication, though. They must throw darts at a board containing random syllables and throw until they find something vaguely resembling a name.

[Velvet Elvis]

I wonder why they didn't seek bipolar approvals.

Because bipolar is hard to test for. There is no one thing called bipolar. Bipolar is 20 different things that fall under the same label. If you get a response yoou never know which of the 20 types of bipolar it responds to.

[SashaSue]

Actually, the usual pattern for AAP's has been that they first get the approval for schizophrenia, then get approved for bipolar disorder.

Not because bipolar is in fact 20 different disorders, or whatever, but because improvement in bipolar disorder is more difficult to measure. The presence or absence of psychotic symptoms is much easier to define and gauge than the presence or absence of mania or depression. So they do the schizophrenia approval first, get the med out on the market, where odds are plenty of doctors will be using it off label for bipolar anyway, then deal with the lengthier process of approval for bipolar.

VE, do you have anything but your own opinion to back up this idea of bipolar being 20 different things that fall under the same label?

[AnneMarie]

Saphris, Geodon and Abilify all were released with bipolar approvals. I just thought it was becoming SOP since the market is there, and that not having the approvals might signal something about this new 'Tude pill.

Because bipolar is hard to test for. There is no one thing called bipolar. Bipolar is 20 different things that fall under the same label. If you get a response yoou never know which of the 20 types of bipolar it responds to.

Can you back this 20 different things statement, and maybe make a little more sense out of that last sentence?

[Aurochs]

The FDA hasn't posted the NDA review materials yet (they need to be redacted, which will take a few months), so I can't check out the full data that the manufacturer submitted.

The PI sheet does mention that the akathisia rate was measured at 22% in the 120 mg/day group, vs 3% with placebo. This is about the same as Abilify's akathisia rate. The maximum recommended dose is 80 mg/day, which carries a lower akathisia risk (15%). Higher doses do not appear to be more effective.

Most of the Additional Warnings are warnings applied to all atypical antipsychotics and describe events observed in one or two other drugs. Agranulocytosis was not observed with lurasidone; nor were any cardiac abnormalities or seizures. But because other drugs in the class have caused these things, the risk can't be ignored.

Clinically, nothing seems to jump out. Of the four trials they submitted data for, one compared its efficacy against another AAP (olanzapine), and it didn't come out as well. I don't imagine that lurasidone is any more effective than any other AAP on the market right now. It seems to be precisely average in pretty much every way except the EPS risk.

As for the Bipolar Disorder indication, the manufacturer is currently running the trials it needs to get approval. I guess they figured that they'd push the drug out now and get some money rolling in, and put in another NDA later.

[AnneMarie]

It looks like they are just testing for Bipolar I depression, not hypo/mania. Interesting.

[Aurochs]

Saphris, Geodon and Abilify all were released with bipolar approvals.

Actually, that's only true for Saphris. Geodon was approved for schizophrenia maintenance on February 5, 2001, and for bipolar mania on August 19, 2004. Abilify was approved for schizophrenia maintenance on November 15, 2002, and for bipolar mania on September 29, 2004.

[AnneMarie]

Saphris, Geodon and Abilify all were released with bipolar approvals.

Actually, that's only true for Saphris. Geodon was approved for schizophrenia maintenance on February 5, 2001, and for bipolar mania on August 19, 2004. Abilify was approved for schizophrenia maintenance on November 15, 2002, and for bipolar mania on September 29, 2004.

Huh. Obviously I didn't know that. Thanks for the clarification.

[Aurochs]

hrm... strange that bipolar isnt in the treatment description but the whole disorder of shizophrenia is. schizophrenia is a very complex disorder, to which only some symptoms are supressed by APs.

This is at least partly because patients with schizophrenia are usually symptomatic even when they're not actively psychotic, while patients with bipolar disorder aren't symptomatic when they're not in a mood state.

It's also the result of the experimental designs used in demonstrating efficacy. All psych drug efficacy studies use a structured interview to determine how symptomatic the subject is, and repeat the interview throughout the study to see if the symptoms go away. Reductions in the score mean less severe symptoms. Schizophrenia symptoms are usually measured with the Positive and Negative Syndrome Scale (PANSS), which accounts for a lot of general and negative symptoms in addition to positive symptoms. For instance, PANSS includes questions that measure anxiety, depression, attention, impulse control, etc. Antipsychotics are known to treat at least some of these persistent symptoms.

The Young Mania Rating Scale (YMRS), which is usually used in the bipolar disorder studies, only measures the severity of manic symptoms. It doesn't measure any other area of functioning. It can't be used to tell the difference between a euthymic bipolar patient and someone who's not mentally ill. That means that drug efficacy studies relying on YMRS can only prove that the drug is effective for treating manic episodes that have already started. Unless they're really long and the YMRS is used to determine when the patient relapses, but that costs a lot of money to do and isn't necessary for marketing purposes.

[tazlina]

Why get approval for bipolar now when you can get it later and thereby extend your patent?

[Aurochs]

Why get approval for bipolar now when you can get it later and thereby extend your patent?

Because getting approval for a new indication doesn't extend the patent term.

[mj1127]

The other day my pdoc was hinting about wanting to try me on this in the new year. I'm not too enthusiastic about the idea.

[tazlina]

Why get approval for bipolar now when you can get it later and thereby extend your patent?

Because getting approval for a new indication doesn't extend the patent term.

Whoops.

[Aurochs]

The lurasidone NDA review package has been posted. A few highlights:

• As expected, lurasidone is not as effective as olanzapine. Interestingly, though, the data don't suggest that lurasidone's efficacy is dose-dependent.
  
• Efficacy studies noted lower plasma concentrations in US patients than in non-US patients. The reason for this is unknown, but it calls into question whether oral dose alone can be used to measure efficacy.
  
• Lurasidone should be taken with food. Taking it without food greatly reduces bioavailability.
  
• EPS (and especially akathisia) is definitely an issue with lurasidone. It's not as bad as haloperidol, but still worse than other AAPs. The review summary also mentions an increase in prolactin, which was also not as pronounced as the increase observed with haloperidol.
  
• Weight changes were not a significant issue: "mean increase of 0.75 kg, compared to 0.26 for placebo and 4.1 kg for olanzapine."
  
• Safety data were reported in a rather sloppy manner. One of the reviewers noted differences between values reported in narratives and those in the actual SAE data and obvious errors in reported lab values, among other issues. However, most of these "other issues" were either minor problems, like a sponsor-identified (and corrected) omission of data, or judgments that she didn't agree with, like the coding of SAEs. The division's director (who wrote the review summary) waved these away as either nonissues (which most of them were) or problems with the FDA itself (poor guidance on writing narratives). However, I can't think of any reason why a data point provided in the SAE database should be different than a data point provided in the narrative for the same event, or why reported lab values should have such obvious issues. That is simply inexcusable sloppiness, but nothing more - they don't represent a data integrity issue, and they don't affect the medical team's conclusions.
  

[Guest bs]

Why get approval for bipolar now when you can get it later and thereby extend your patent?

Because getting approval for a new indication doesn't extend the patent term.

[Warhose8]

I took latuda for about 5 days and developed severe akathisia/parkinsonism - far worse than any akathisia i'd experienced ( for instance they tried me on geodon and abilify, which both gave me mild akathisia and abilify gave me parkinsonism, and unfortunately my doctor hadn't informed me of the eps side effects or the fact that there was medication to treat the akathisia. Anyways, the latuda was given to me in rehab for opiate detox mood stablization. The akathisia I got from this drug actually sent me back to the mental ward because I was afraid I might hurt myself and I didnt know about cogentin ect. I now take saphris and take artane which seems to relieve the eps I get from saphris. So beware of latuda guys its side effects are nasty. Btw, Latuda sounds like an old black lady's name to me. Mind yo aunt latuda boy or imma whip ye with a hickory switch

[AnneMarie]

I took latuda for about 5 days and developed severe akathisia/parkinsonism - far worse than any akathisia i'd experienced ( for instance they tried me on geodon and abilify, which both gave me mild akathisia and abilify gave me parkinsonism, and unfortunately my doctor hadn't informed me of the eps side effects or the fact that there was medication to treat the akathisia. Anyways, the latuda was given to me in rehab for opiate detox mood stablization. The akathisia I got from this drug actually sent me back to the mental ward because I was afraid I might hurt myself and I didnt know about cogentin ect. I now take saphris and take artane which seems to relieve the eps I get from saphris. So beware of latuda guys its side effects are nasty. Btw, Latuda sounds like an old black lady's name to me. Mind yo aunt latuda boy or imma whip ye with a hickory switch

Interesting.

Latuda is the first AAP that feels like a sugar pill when I take it. That's from the first day. Absolutely no side effects, and I certainly have had deal breaker side effects on AAPs.

Just goes to show, meds affect folks differently and you never know for yourself until you try them.

[maus]

Really ? Do you take a high dose of antipsychotics ? Have you ever been on Risperdal and at what dose ?

Don't you feel with Latuda tired and sedated ?

Thanks

Interesting.

Latuda is the first AAP that feels like a sugar pill when I take it. That's from the first day. Absolutely no side effects, and I certainly have had deal breaker side effects on AAPs.

Just goes to show, meds affect folks differently and you never know for yourself until you try them.

[jt07]

Really ? Do you take a high dose of antipsychotics ? Have you ever been on Risperdal and at what dose ?

Don't you feel with Latuda tired and sedated ?

Thanks

I realize that your post was directed at Stacia, but I just want to emphasize that meds affect us all differently. I took Risperdal at 4 mg, and it was like a sugar pill to me. No side effects whatsoever. Unfortunately, I didn't really get many good effects - just some clearer thinking and some brightening, but my depression didn't relent.

I now take Abilify, but at only 5 mg. I causes me slight sedation. Many people find that 5 mg of Abilify is activating. Like I said, meds affect us all differently.

[AnneMarie]

I've only been on medium AAP doses. Well, 20mg Zyprexa once and that was a very akathisia experience I don't want to live again.

I'm only on 40mg of Latuda so far. Hoping to keep it low. It's still a sugar pill that strangly helps keep my brain quiet. No sedation whatsoever.

Risperdal I took up to 4mg with only the very mildest hint of sedation.

Seroquel no longer puts me to sleep whether its 25mg-200mg. Sleeping pills don't work, either. I'm rather screwed sleep-wise.

Really ? Do you take a high dose of antipsychotics ? Have you ever been on Risperdal and at what dose ?

Don't you feel with Latuda tired and sedated ?

Thanks

Interesting.

Latuda is the first AAP that feels like a sugar pill when I take it. That's from the first day. Absolutely no side effects, and I certainly have had deal breaker side effects on AAPs.

Just goes to show, meds affect folks differently and you never know for yourself until you try them.