Ketamine for Bipolar Disorder

Today, the NY Times reported on a double-blind, placebo controlled study using ketamine to treat severe depressive symptoms in a small group of patients with Bipolar Disorder. As was rightly noted in the article, it's highly debatable that the study truly remained blinded as the effects of ketamine are well-known and were likely evident to the patients within an hour of infusion. However, the study is interesting in terms of understanding how yet another product used off-label can provide assistance to this long-suffering population. Now, the use of an oft-abused drug like Special K in a population prone to dangerous behaviors is another question that should be addressed before physicians start prescribing it.

DSM V Changes Will Increase Atypical Antipsychotic Use

The public review period for the proposed DSM V changes has begun, and there is much chatter. One change that I believe is a good one for the reasons discussed here is the creation of the disorder known as Temper Dysregulation Disorder (TDD). This disorder should significantly decrease the diagnosis of bipolar disorder in children. With bipolar seen as a stigmatizing and lifelong disorder, the prospects for children diagnosed with the condition were not good, and the label itself could be self-defeating and self-esteem destroying. To tag a child with such a severe disorder is truly dangerous from a psychological perspective. Nonetheless, psychiatrists must provide diagnoses in order to insure insurance reimbursement for their clients at the least. This new disorder will allow psychiatrists who had been reluctant to label a child as bipolar to have a new more attractive alternative tag to attach that is time-limited to childhood and carries none of the stigma of the bipolar diagnosis.

So, we'll see a decrease in the diagnosis of bipolar disorder, but this will be more than offset by the diagnosis of TDD. I can see the atypical psychotic marketing teams sitting in their conference rooms now correlating the symptoms of TDD and bipolar to see which TDD symptoms they can lawfully market for their product because they also happen to be symptoms of bipolar. It may not even be necessary since atypicals are the clear choice among psychiatric drugs to treat the symptoms of TDD. You might try an anti-depressant, but as soon as the parents complain, the next step will be the atypical.

How long before the first company steps up to bat in a clinical trial to get the first antipsychotic label for TDD? Can anyone say patent extension?

Astrazeneca's Seroquel Bipolar Depression DTC TV Ad Hits the Airwaves

For a multi-billion dollar drug with an opportunity to have patient-driven prescriptions, it's surprising that it's taken this long for Astrazeneca to finally get around to a DTC TV campaign for Seroquel XR. Given that the ad is so depression-focused I wonder if the marketing team at AZ had been making this ad for the depression indication for which they're still waiting on FDA approval. If you mute the ad and just look at it, it could easily be an ad for any of the products currently advertising for major depression. I wonder if they just got tired of waiting on the approval and had the ad agency change the voiceover to accomodate the comparable indication that they do have in bipolar depression. Just an outsider's guess.

The ad itself is pretty depressing. I know the Abilify ads were criticized for being too "sunny" in their conclusions, but geez this ad could use a little. If I wasn't depressed before viewing it, I sure am now. The fair balance is rough too. All 53 seconds of it. It's always hard to hear the drug you're taking has an increased risk of DEATH.

The one thing this ad will accomplish if it doesn't get lost in the other 85 seconds is that some patients can take just 1 pill. It's the last thing we hear before the fair balance kicks in. This of course is basically the only advantage of Seroquel XR over it's soon-to-be-generic parent Seroquel. However, the suggestion is erroneous. Patients suffering from Bipolar disorder rarely can take a single medication to control their systems, esp. given the associated comorbidities to manage as well as the drugs to counter act the side effects of Seroquel. Still, the 1 pill promise could drive patients to talk to their doctor about Seroquel which is the first step in this ad paying off for AZ. It will be interesting to see if their print campaign is revised to coincide with the TV spot as well as whether AZ will seek better ad spot availability by creating a 60 second version.

First Generic Atypical Antipsychotic (Risperdal becomes risperidone)

Yesterday Teva announced they received FDA approval to produce a generic version of Risperdal. We all knew this was coming. Teva was ready with product to ship and JNJ was ready with their own in-house generic version in hopes of cannibalizing some Teva sales at the expense of their former cash cow.

What does this mean for the common man?

Well if you're schizophrenic, bipolar, autistic, or an off-label user, it means that the price you pay just got a whole lot cheaper AND after Teva's 180 days of exclusivity as the sole competitor allowed to sell risperidone, the price will drop even lower as more competition enters the market.

If you're a sale rep. for Invega (the bastard child of Risperdal), your sales goals just got a wee bit more difficult now didn't they because who wants to buy Risperdal-lite when you can get the original for pennies on the dollar. Wonder what that already stellar *saracasm* Invega uptake curve is gonna look like now.

And what if you're Abilify, Geodon, Seroquel or Zyprexa? Well, you hope and pray that your marketing and sales folks have done a good job differentiating their product from the competition because the price differential between you and the generic just went exponential.

And what of the insurers you may ask. Can you say fail first? I'm sure it's already begun.

Ooh, exciting times in the Atypical Antipsychotic Market!

Abilify for the Kids

Bristol-Myers Squibb released their earnings last week. No real news on the Abilify front. It continues to grow year over year and now has the pediatric bipolar and adolescent schizophrenia indications in its pocket to be the kid-friendly atypical anti-psychotic. Analysts didn't really press on Abilify since the Mead Johnson IPO idea started all their wheels turning.

Guess we can look for the Abilify reps in our pediatrician's office the next time the kids' need a sports physical.

Atypical Anti-psychotic Monopoly

Perhaps it's more of a quintopoly. Since Abilify's launch in late 2002, Astrazeneca, Jansen, Eli Lilly, BMS/Otsuka, and Pfizer have had free reign over the atypical anti-psychotic market. Starting with schizophrenia but gradually expanding to bipolar disorder, autism, major depression, and generalized anxiety disorder coming soon, these products are infiltrating every corner of the mental health market in all age groups. I don't have a lot to say here, just that's interesting how the increasingly more restrictive FDA is crushing potential competition through its tenor. bifeprunox is dead. asenapine is alive and may actually get the bipolar mania label. And, Fiapta (iloperidone) is crippled by its patent life, lack of sales force, and second-line at best status in schizophrenia.

Damn it must feel good to be one of the big five.