August 27, 2009

Here Comes Another New Antipsychotic

This one is called lurasidone and it's developed by Japan's Dainippon Sumitomo Pharma. The company is so pleased by its phase 3 trials results that it's going to submit it to the FDA early next year for approval as a treatment for schizophrenia. If approved, the drug would be the third new antipsychotic approved by the FDA in about one year's time. Vanda's Fanapt was approved earlier this year although it's not yet on the market and Schering-Plough's Saphris, which was approved earlier this month for use in schizophrenia and bipolar disorder.

It'll be interesting to see how all these new drugs work out in a field crowded with second generation antipsychotics, especially with some of those drugs being off-patent (Risperdal) or about to come off-patent (Zyprexa and Seroquel). These new drugs would have to be pretty spectacular performers--or their makers would need to come up with an appropriate smoke-and-mirrors marketing campaign--to capture many sales because they'll be competing with mostly generic drugs.

A former FDA reviewer has called Saphris flat-out unsafe and there's been some skepticism expressed about just how great Fanapt is as well.

The companies with the new drugs have so far mostly claimed that they work as well as nasty drugs like Zyprexa while having fewer side effects. To my ears, that sounds like what Lilly and its shills in academia were saying about Zyprexa vis a vis Haldol in the 1990s. We know how that turned out.

Here's what a researcher who ran trials of lurasidone said about the drug:

"'If you look at the weight gain, the lipid changes, it's among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel,' [Herbert] Meltzer [of Vanderbilt University] said."

Benign and antipsychotic are two terms that I don't think anyone can use together with a straight face.

Posted by Philip Dawdy at August 27, 2009 01:08 PM
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Comments

Peace be with you Philip

Welcome back, and sorry about that job thing (I'm praying for you). Again I agree with you this is the same rhetoric we've heard before.

You should consider writing a book, or creating a documentary. If not for rent money, then for the betterment of humankind.

love eternal
tad

Posted by: tad at August 27, 2009 07:44 PM

It will be really entertaining to hear all of the justifications why we should switch to these new meds, just as the patents on Zyprexa, Seroquel, etc. are expiring. And by entertaining, I mean sickening.

Posted by: kimbriel at August 27, 2009 10:03 PM

Strange, isn't it, how meds fall out of favour when their patents expire.

Posted by: Francesca Allan at August 28, 2009 11:35 AM

I understand that you are skeptical and are looking out for your readers, but some of us are deperately, desperately in need of these new drugs! When zyprexa has you gain 30lbs, increased cholesterol and glucose, and makes you too dumb to speak, and then geodon doesn't work, seroquel works for awhile then poops out, and risperdol, abilify and invega all increase prolactin to the point of lactating (breast milk). I've been through them all as well as all the other off-labels like neurontin, keppra and mirapex. I take lithium and lamictal, and have been on depakote and trileptal.

I am out of options. So I wait with bated breath for these new drugs because one of them may just work for me. I pray for it, I beg for it. They are all different, they all have different side effect profiles. The need is there so they will continue to try to develop better drugs that besides working, people can actually live with taking.

Remember me when you advise whatever followers you have, or those directed to you through a search, that many of us need these new drugs. Bless you for not having the experiences I've had with these medicines, but don't think you are an authority. These drugs work, they are much needed, and they can't come out fast enough for me. Just ask my 6 yr old and husband. We are forever waiting for that next drug to see if it's the on that makes mommy ok!

Posted by: Alicia at September 23, 2009 07:49 AM

After being on the heavy hitters like Seroquel Zyprexa and Risperdal, I've been experiencing the terrible side effects. I can't help but be very skeptical about the 'new kids on the block'.

My experience is all these new wannabes all activate the hell out of people and cause more akathisia and anxiety. Sure, they don't make you fat, but I don't think they are an acceptable substitute. Just look at how Abilify has been advertised and watch all these new 'me-too' drugs being created to cash in on the new trend.

I hope in 50 years they can actually make decent anti-psychotics for the world to use and not put everyone through hell like they do now.

Posted by: Scott at November 24, 2009 03:24 PM
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