FDA Rejects Vraylar sNDA for Negative Symptoms of Schizophrenia

Well that sucks…Has anyone successfully treated their negative symptoms with Vraylar?
http://www.psychiatryadvisor.com/drugs-in-the-pipeline/vraylar-cariprazine-supplemental-new-drug-application/article/695331/
Article:
The Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter in response to Allergan’s Supplemental New Drug Application (sNDA) for Vraylar (cariprazine). Vraylar, a once-daily oral atypical antipsychotic, is approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. The sNDA proposed Vraylar as treatment of negative symptoms (ie, loss of motivation, social withdrawal, anhedonia) associated with schizophrenia in adult patients. In the letter, the FDA stated that its preliminary appraisal found the sNDA not sufficiently complete to permit a substantive review. “We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps,” said David Nicholson, PhD, chief R&D officer, Allergan. Pharmacodynamic studies of cariprazine have shown that it acts as a partial agonist at dopamine D3 and dopamine D2 receptors, and has a high binding affinity at the serotonin 5-HT1A receptor. Its exact mechanism of action in schizophrenia and bipolar I disorder is unknown. Vraylar is available as 1.5mg, 3mg, 4.5mg, and 6mg strength capsules in 30- and 90-count bottles as well as 7-count blister packs. For more information call (800) 433-8871 or visit Vraylar.com.

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It didn’t work on my positive symptoms but did help keep me more motivated.
It also allowed me to feel pleasure in certain activities like hearing music.
I was only on it for a short while.

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Well that’s encouraging

Did you try abilify, which is similar to vraylar? If so, was Abilify effective in the motivation and pleasure department for you as well? (how would you compare the 2)

@Wave

I tried both.
Vraylar was more effective on Negative symptoms.
They are both activating meds.
Vraylar was more stimulating out of the two.

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For what it’s worth, I just got 2 additional anecdotal experiences with Vraylar from people in a schizophrenia forum on facebook, here’s what they had to say to my post in which I asked if someone had used it for negative symptoms (motivation and pleasure):

first person: Yes. It doesn’t help that much with it
me: So it helps a little bit?
first person: Yes
me: Okay, and had you tried Abilify before? If so, would you say that vraylar is better than abilify for negative symptoms? And lastly, have you been on vraylar for a long time? (just trying to see if there’s a chance that the improvements fade and vraylar becomes less and less effective with time…)
first person: Abilify didn’t work for anything with me and gave me akathesia. I’ve been on vraylar about a year
me: Would you say that vraylar concretely gives you motivation to do stuff and pleasure?
first person: I experience loss of interest and emotion and flat affect but some motivation has Improved.

second person: Yes. Amazing drug
me: how would you describe your negative symptoms prior to taking vraylar? Is it a loss of interests , a loss of motivation , the inability to have pleasure while listening to music for example, etc?
second person: I’m not exactly energetic but I can now accomplish things and though things like reading is difficult I derive pleasure from it. It really improved the quality of my life
me: By any chance did you try Abilify or Rexulti before trying vraylar?
second person: No. The antipsychotic I was on was geodon. Which kept me from going crazy but not much else
me: Do you recall how long it took for you to see improvements in your ability to derive pleasure after starting Vraylar? Was it after the first dose?
second person: About the first few days of taking 3.0 mg of it.
me: Have you been on it for a long time? (just to see if the improvements are sustained over time…because some meds just stop working after a while)
second person: I believe I’m towards the end of the second month of taking it. I’m on 6.0 mg
me: Did you increase to 6.0mg because 3.0mg was starting to be ineffective? or because you wanted to reach the maximum dose in order to reach the maximum benefits from the med? (do you feel a difference between 6.0mg and 3.0mg)
second person: I wanted the maximum benefit from it.
me: okok, and have you felt a significant difference between all the dosages that you’ve tried?
second person: I felt a boost with each dosage

Takeaways:
-For some it may mostly work on motivation, more so than on pleasure/interest. For others, it can definitely increase the ability to derive pleasure. For some it will be a small improvement, but significant enough to make a difference in your life.

-Improvements can still be there after a year on it

-For those for whom Abilify didn’t work, Vraylar has the possiblity to work (both work in a similar way, but vraylar hits stronger on the dopamine receptors so that may explain why it may work better for negative symptoms than Abilify)

-When it works, it might work very quickly for negative symptoms (doctors always think all meds need a full 8 weeks before reaching significant benefits, but for negative symptoms and dopaminergic drugs like vraylar, rexulti, and abilify it seems different)

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Another Vraylar/cariprazine success story: I had messaged this person about Vraylar asking for more info since he had said in a reddit post he had success with it.:

“Hey there,
I’ve never tried abilify so I can’t compare the two.
I also experienced severe anhedonia. I dropped out of school. Quit my job. And spent 90% of the time in my room watching YouTube videos. Since I started vraylar I started working full time again and I’m back in school taking a part time class load. I also go to the gym about 5 days a week. I’ve been taking it since May, so for about 5 months now, and I’m still on the lowest dose, 1.5 mg. I haven’t felt it poop out. I feel just as good as when I first started taking it. Within one week after starting it I was sending out applications and going to the gym in the mornings. Pretty incredible stuff. I have Bipolar I with Psychotic Features. Basically the same thing as schizophrenia. My psychiatrist told me the only reason I was diagnosed with that was because it’s more socially acceptable lol.”

That was the reddit post:
"Honestly, Vraylar has been one of the best experiences I’ve ever had with any psychiatric medication. It has turned my life around. Not only has my mood stabilized but I’m sleeping better and I’ve even noticed improvements in my motivation and cognitive ability. The only side effects I had were during the first two months of taking the drug. I experienced nausea, muscle stiffness, joint aches, and weakness. Once my body adjusted, I felt great!

And in another post he had said:
“I’m a bit restless, but that’s about the only lasting side effect.”

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