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News Axsome's depression drug enters competitive market after U.S. approval

thegreenhand

thegreenhand

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Axsome's depression drug enters competitive market after U.S. approval​

Amruta Khandekar
Reuters
19 Aug 2022

Excerpt:
Aug 19 (Reuters) - Axsome Therapeutics Inc (AXSM.O) on Friday gained U.S. approval for its treatment for depression, giving more than 20 million Americans affected by the disorder a new option in a market crowded by older drugs.

Shares of the U.S.-based company, which expects to launch the drug in the fourth quarter, surged 25% in early trade.

The drug, Auvelity, is a new class of treatment that reduces the symptoms of depression as early as one week, giving it a potential edge over older antidepressants, which can take up to six weeks to show effect.
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From the company press release (bolding is from me):

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.1 AUVELITY is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.1-4 The rapid antidepressant effects of AUVELITY were sustained at all subsequent timepoints.1 AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD.3 Axsome anticipates AUVELITY to be commercially available in the U.S. in the fourth quarter of 2022.
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Snafu in the Void said:
... its just DXM + Wellbutrin?

Lmao
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The company claims:

“The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase the increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of Auvelity in the treatment of depression is unclear.”

I suppose it’s interesting that the bupropion increases DXM blood concentrations, but it seems like a money grab to me (what new psych drug isn’t tho lol)
 
Snafu in the Void said:
It's stupid how pharma companies just combine 2 old and easily available drugs and market it as some new revolutionary breakthrough.
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Yep, you've just got to run the trials and if the data comes out good, you're golden. 🤷‍♂️ It's not the most exciting science in the world but that's how the game works. It's up to physicians (and national formularies, Medicare, etc.) to do the actual triaging.

These sound like they could be fun in above-prescribed doses...
 
S.J.B. said:
These sound like they could be fun in above-prescribed doses...
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dunno, I assume the DXM dose is quite low relative to the bupropion

either way it would be a shitty high, I've never considered abusing bupropion even in my most desperate days... but I guess others do it

and DXM is a shitty high IMO

but I can see other people abusing it out of desperation
 
Snafu in the Void said:
dunno, I assume the DXM dose is quite low relative to the bupropion

either way it would be a shitty high, I've never considered abusing bupropion even in my most desperate days... but I guess others do it

and DXM is a shitty high IMO

but I can see other people abusing it out of desperation
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I took it once and it was okay, not ketamine by any stretch, but the worst part was all the fake sugar in the syrup that destroyed my stomach, and you wouldn't get that with pills at least. But I must admit I've never tried buproprion.
 
I think I read somewhere that bupropion has the nickname ‘prison crack’ due to the prevalence of its recreational use among that community. Apparently it’s only good when insufflated…

I tried it as an antidepressant for about a month but had to stop as it was making my suicidality much worse. I felt kind of manic tbh

I enjoyed the DXM the one time I tried it. I made the mistake of thinking it’d be much more uplifting like a psychedelic and decided I’d go for a bike ride. Took one puff of weed at the endpoint of the rail trail, and somehow made it back as it was all hitting my system. Idk how I didn’t crash tbh

I got home, crawled into bed and listened to Miles Davis on some nice headphones. Overall a very positive experience. And the week after was a nice afterglow free of nearly all depressive symptoms. I can definitely understand why they chose it
 
It might be a decent medication for some but idk about most of the population, I am allergic to DXM. An OTC dose for a cough makes me trip balls, full fledged dissociation from a mere 25mg. Something tells me increasing the amount in my blood stream would make this an ER visit drug. Sounds very dangerous. Doctors should ask if patients have taken cough syrup OTC before and what effect it had on them. Otherwise this drug could kill people.
 
I came here to post this after finding out today.

I’ve tried this combination in the past (taking Robitussin cough gels while prescribed Wellbutrin) and it honestly works quite well. Certainly better than anything on the market right now.

I’m really looking forward to seeing how this pans out.

Snafu in the Void said:
I also see people abusing this stuff, since people already abuse both DXM and wellbutrin
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Sorry Snafu, I have to disagree with you here.

I was on Wellbutrin for nearly 2.5 years. It has little to no abuse potential because it is an extremely unpleasant drug even at the high end of therapeutic dosages.

The amount of Auvelity you’d need to take to get any significant DXM high (past the mildest of plateau 1 effects) would cause severe stomach pain, hypertension, and other issues from the quantity of Bupropion in your system.

People will just go to the drug store and buy DXM syrup or order Robocough tablets online.
 
arrall said:
It has little to no abuse potential because it is an extremely unpleasant drug even at the high end of therapeutic dosages.
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did you ever try it via other ROAs, in particular intranasally ?
 
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mtu mwendawazimu said:
Only since this is now a conversation, I have IV and insufflated Wellbutrin.

Think what you may, but my first stim overdose was almost Wellbutrin.

It has abuse potential. And I think others may agree.
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can i ask what it felt like? is it comparable to any other stims you've tried ?

the main place i've heard of abusing wellbutrin is in prisons, but i'm sure there are others like you who tried it just cause (I actually have half a bottle somewhere that i was saving to maybe try insufflated one day lol...)
 
thegreenhand said:
can i ask what it felt like? is it comparable to any other stims you've tried ?

the main place i've heard of abusing wellbutrin is in prisons, but i'm sure there are others like you who tried it just cause (I actually have half a bottle somewhere that i was saving to maybe try insufflated one day lol...)
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IV made me nauseous, "stimulated", but not very euphoric, after knowing what cocaine was.

Snorting that shit is what had me close to passing out. It's not more intense, but it's just so much faster since you need to do a cold water extraction to slam it and all that shit I just wanted the quickest feeling.
 
mtu mwendawazimu said:
IV made me nauseous, "stimulated", but not very euphoric, after knowing what cocaine was.

Snorting that shit is what had me close to passing out. It's not more intense, but it's just so much faster since you need to do a cold water extraction to slam it and all that shit I just wanted the quickest feeling.
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i feel like my heart would explode if i IVed it lol. even just one month of daily oral dosing (as prescribed) had me feeling like my heart was pounding all the time.

i'll probably pass on the idea of railing it i think lol

i can definitely see why someone who has no access to better stims might choose it tho
 
thegreenhand said:
did you ever try it via other ROAs, in particular intranasally ?
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No, I took it as prescribed other than when I would occasionally accidentally take a dose twice and have a day or two of insomnia and agonizing stomach pain.

I’d honestly say that caffeine has more abuse potential and recreational value, as someone who as a teenager would take hundreds of mg at once of anhydrous caffeine tablets due to it having little effect on my ADHD at reasonable dosages.
 
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