Shirah Vollmer MD

The Musings of Dr. Vollmer

Brintellix and Rexulti

Posted by Dr. Vollmer on September 18, 2013

 

 

 

 

 

https://shirahvollmermd.wordpress.com/2010/01/24/luaa21004-a-game-changer/

http://en.wikipedia.org/wiki/Vortioxetine

http://www.prnewswire.com/news-releases/fda-accepts-takeda-and-lundbecks-submission-of-the-new-drug-application-for-vortioxetine-for-the-treatment-of-major-depressive-disorder-183210241.html

http://www.pharmabiz.com/NewsDetails.aspx?aid=75465&sid=2

“In vitro studies indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin (5-HT) transporter (SERT). In vivo non-clinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.”

 

We need new modalities of treatment. We have SSRIs, SNRIs, which changed our game in 1988 dramatically, but since then, the rate of progress has slowed considerably. Now, we have deepened our field by understanding two new important aspects of serotonin functions. There are SEVEN serotonin (5-HT) receptors subtypes. http://en.wikipedia.org/wiki/5-HT_receptor. Second, as I posted about in 2010, there is a sertonin transporter, which can be altered leading to a change in the amount of serotonin floating around the receptors. This understanding opens the field to more targeted drugs. In October, 2013, the FDA will decide whether to approve Vortioxetine, likely to be called Brintellix or Rexulti, for the treatment of Major Depression. New drugs give hope to the many folks who feel despair with their symptoms, especially if they have tried multiple modalities, with little success. We, psychiatrists, call these folks “refractory,” but in fact, their persistent symptoms point to our limited tool box. Expanding our tools, of course, can also come with risk, but in the world of depression treatment, our pharmacological interventions have been exciting because the risk/benefit ratio is so favorable. In essence, the upside far outweighs the downside. This change in the risk/benefit ratio is how Prozac changed our world. Prozac did not bring about greater efficacy than our old tools of tricyclic antidepressants, but it did change this ratio to expand the number of people we could try to help. Further, Prozac also taught us that personality characteristics, such as impatience, could significantly improve with pharmacological intervention. So, we could treat more people, and we could treat folks who did not have a psychiatric illness, but who did suffer from irritability and then subsequent relationship issues. This Prozac story gives us hope with each new drug that our world can change again, in ways we do not even understand yet. Drugs come out on the market, and then we learn more about them through the individual tales of experience. Listening to how people experience their medication, to reference my last post, is a fun part of my job. I listen not only to how they experience the medication, but how they choose to tell me how they experience their medication. Having a new medication to use, creates the wonderful combination of excitement and fear, which with trust in the FDA, makes the fear tolerable, and the excitement grand. Sure, there is a lot of post-marketing learning, but the FDA gives us a safety net to explore the uses of new medication or new devices. It is interesting that each country has their own oversight organization, so one country might approve a medication, while another country waits for more data. I do not know what the FDA will do, but the data look promising that Brintellix (the likely name) will see the light of day, giving me a new tool. Once again, I feel appreciative for my medical background which gives me the privilege of using these tools. Once again, stay tuned.

14 Responses to “Brintellix and Rexulti”

  1. Shelly said

    How is Brintellix any different than the other modalities on the market today and why do you think it will bring relief to patients when those other modalities haven’t? What about ECT? Have you ever used it in difficult-to-treat patients? What are the pros and cons?

    • “Brintellix is expected to be one of the most successful new agents in the unipolar depression markets of the US, France, Germany, Italy, Spain, the UK and Japan, because of its potential for positive effects on cognition and its reasonably tolerable side effect profile demonstrated to date, according to the research, from Decision Resources. The study expects Lundbeck and Takeda to position Brintellix (vortioxetine) as a first-line option for elderly patients with depression and as a second-line therapy in patients who fail a generic selective serotonin reuptake inhibitor (SSRI).” http://www.pharmatimes.com/article/13-08-07/Antidepressant_Brintellix_tipped_as_blockbuster.aspx

      In other words, it should help depressed folks think more clearly.

      In terms of ECT, it is still a viable treatment option for refractory depression. The pros are that it is relatively safe, and the cons are that it can cause temporary memory issues.

  2. no name said

    FDA seems rather biased. Agomelatine was rejected probably due to the influence of the farce known as STAR*D study. SSRI’s are not a one size treats all success story. I don’t think that any antidepressant qualifies as a “first line of treatment”, considerations should be made on a patient by patient manner. The psychiatric drugs are not bad, however, the manner in which they are being applied is flawed. That said, I hope Brintellix makes it to market, SSRI’s have dramatically improved in quality over the years, the last one that passed, Vortioxetine has a rather good side effect profile minus the chronic diarrhea many patients are likely to experience. The FDA… meh.

    • Hi no name- thank you for your comments. If you are comfortable, let me know how you found me. Thanks again.

      • Hi Ricardo,
        Thanks for chiming in. Sexual side effects are the big question. There is a high likelihood that sexual side effects will be less, but post-marketing analysis will be critical for a deeper understanding of this issue. Thanks again.

  3. ricardo moreira said

    And about sexual side effects?

  4. No Name said

    Here’s the cute little rundown for Vortioxetine:

    Hopefully it doesn’t wind up rejected like Agomelatine, which is an awesome antidepressant (depending on patient) especially for those with insomnia.

  5. No Name said

    The FDA approved vortioxetine.

  6. Shirah said

    Thanks!

  7. No Name said

    Prescribing info, here:
    http://us.brintellix.com/

  8. Michael said

    I’ll tell you what I believe, I believe that Brintellix may very well be one of the first effective drugs for Borderline Personality Disorder. I also have some interest in medications for ADHD (not the stimulants) and treatment of BPD. I have ADHD myself, but have had emotional problems at times which might be viewed as “BPD” like, but I am not dramatic or attention seeking.

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