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anyone heard of lybalvi?  It was advertised in my facebook feed and I hadn't heard of it.

It wouldn't be an option for me because there's no way my insurance will approve both it and fanapt (which is already way off the formulary and takes a statement of medical necessity every year or two).  Alsoit looks like it might impact the kidneys, which for me were already impacted by lithium (though they've recovered).  But I'm just curious since I hadn't heard of it. 

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On 3/6/2022 at 6:50 AM, dancesintherain said:

anyone heard of lybalvi?  It was advertised in my facebook feed and I hadn't heard of it.

It wouldn't be an option for me because there's no way my insurance will approve both it and fanapt (which is already way off the formulary and takes a statement of medical necessity every year or two).  Alsoit looks like it might impact the kidneys, which for me were already impacted by lithium (though they've recovered).  But I'm just curious since I hadn't heard of it. 

I heard of it from a post on here. I googled it too. I didn’t know it impacted kidneys. I don’t know really anything about it. I didn’t even ask my dr about it. 

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On 3/6/2022 at 7:50 AM, dancesintherain said:

anyone heard of lybalvi?  It was advertised in my facebook feed and I hadn't heard of it.

It wouldn't be an option for me because there's no way my insurance will approve both it and fanapt (which is already way off the formulary and takes a statement of medical necessity every year or two).  Alsoit looks like it might impact the kidneys, which for me were already impacted by lithium (though they've recovered).  But I'm just curious since I hadn't heard of it. 

It’s basically zyprexa plus an opioid antagonist that is supposed to cut down on metabolic side effect 

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Lybalvi combines olanzapine found in Zyprexa with a "new" opioid antagonist called samidorphan, which is a modification of the structure of naltrexone (3-Carboxamido-4-hydroxynaltrexone to be precise). Naltrexone has been used for some time as an appetite suppressant, most notably in combination with bupropion. So while samidorphan is a new compound, the purpose for which it was created is not a new one. The major differences between naltrexone and samidorphan are that samidorphan has ~5-fold greater selectivity for antagonism of MOR (mu-opioid receptors) over KOR (kappa-opioid receptors) and DOR (delta-opioid receptors) and it has a significantly better bioavailability.

The antagonism of MORs causes a suppression of the appetite, which counteracts the appetite-inducing effects of olanzapine, which are caused by 5HT2C antagonism. So whether samidorphan actually directly improves metabolic parameters like glucose and lipids, I don't know. However, at the absolute least, those parameters should improve downstream from the fact that you aren't eating everything that isn't nailed to the table.

There is some very new science as well that opioid receptor modulation may be useful in schizophrenia. And blockade of KORs has been shown to have antidepressant effects. Samidorphan binds to KORs with high affinity as a partial agonist with very low intrinsic activity making it a functional antagonist. So samidorphan may have antidepressant potential as well.

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3 hours ago, browri said:

Lybalvi combines olanzapine found in Zyprexa with a "new" opioid antagonist called samidorphan, which is a modification of the structure of naltrexone (3-Carboxamido-4-hydroxynaltrexone to be precise). Naltrexone has been used for some time as an appetite suppressant, most notably in combination with bupropion. So while samidorphan is a new compound, the purpose for which it was created is not a new one. The major differences between naltrexone and samidorphan are that samidorphan has ~5-fold greater selectivity for antagonism of MOR (mu-opioid receptors) over KOR (kappa-opioid receptors) and DOR (delta-opioid receptors) and it has a significantly better bioavailability.

The antagonism of MORs causes a suppression of the appetite, which counteracts the appetite-inducing effects of olanzapine, which are caused by 5HT2C antagonism. So whether samidorphan actually directly improves metabolic parameters like glucose and lipids, I don't know. However, at the absolute least, those parameters should improve downstream from the fact that you aren't eating everything that isn't nailed to the table.

There is some very new science as well that opioid receptor modulation may be useful in schizophrenia. And blockade of KORs has been shown to have antidepressant effects. Samidorphan binds to KORs with high affinity as a partial agonist with very low intrinsic activity making it a functional antagonist. So samidorphan may have antidepressant potential as well.

I get it now. Thank you @browri! I didn’t understand what they paired Zyprexa with until you said it was a modification of naltrexone. This all makes sense to me now. A light bulb has been turned on!

I don’t know if it’s worth pursuing for me personally, because I’m losing weight, but I can see it being useful for those who benefited from Zyprexa but had weight gain. This way they shouldn’t gain weight yet still reap the benefits of the Zyprexa brain glue. Nifty!

And @dancesintherain I saw a copay card on the official website if that is of any help to you? Or if your pdoc could write a letter to your insurance or something? Not sure. 

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16 hours ago, Wonderful.Cheese said:

I get it now. Thank you @browri! I didn’t understand what they paired Zyprexa with until you said it was a modification of naltrexone. This all makes sense to me now. A light bulb has been turned on!

I don’t know if it’s worth pursuing for me personally, because I’m losing weight, but I can see it being useful for those who benefited from Zyprexa but had weight gain. This way they shouldn’t gain weight yet still reap the benefits of the Zyprexa brain glue. Nifty!

And @dancesintherain I saw a copay card on the official website if that is of any help to you? Or if your pdoc could write a letter to your insurance or something? Not sure. 

Lybalvi will be a tricky one when it comes to insurance. It could go either way. Usually, when an old medication is reintroduced in a combo med, insurance companies rarely touch it if both medications can be given as generics. An example of this is Contrave which is a combination of 8mg naltrexone with 90mg of bupropion. They're sustained release tablets that need to be taken twice a day. For the bupropion component, you can take 100mg Wellbutrin SR twice a day, but naltrexone only comes in 50mg tablets that are scored once. If you split them into quarters you could get 12.5mg if you somehow managed to not destroy the tablet.

I guess what I'm getting at is that Contrave was an example of pharmaceutical evergreening, and the method was using doses of bupropion 90mg and naltrexone 8mg, which aren't available as generics, as well as using a controlled release, low-dose form of naltrexone that you can't find anywhere else on the market. However, insurance companies still choose not to cover it because both medications can be acquired in generic forms. I generally regard my insurance as being quite permissive (Premera Blue Cross), and they still don't cover Contrave.

With Lybalvi, the samidorphan component is technically a new chemical entity even though it is a modification of the naltrexone structure. The manufacturer may argue that samidorphan has greater bioavailability than naltrexone, but naltrexone is still only administered once a day. So inventing samidorphan was more about creating a new product that couldn't be reproduced with generic substitution.

Insurance companies will see right through this. The samidorphan component doesn't provide any additional efficacy according to trials. It just improves side effects. This is notable, however, because improving the side effects of olanzapine enough could be what's needed to make a more useful medication. Olanzapine is widely regarded as one of the most effective atypical antipsychotics (after clozapine), but in recent years, it has been relegated to second-line because of the exorbitant metabolic dysfunction. If insurance companies had it their way, more people would take olanzapine and clozapine because of their high efficacy, but then they would be stuck also paying out for metformin among other medications to keep metabolic dysfunction at bay. If there was a form of olanzapine that didn't trigger additional health issues, it may be worth paying for (although list price for Lybalvi looks to be ~$1300/30 tabs).

Just checked my own insurance and it's actual on-formulary as a non-preferred brand. Requires prior authorization, but the fact that it's even listed on the formulary as covered is surprising to me. Although it may prove my point above. Have the patient try olanzapine first. If their metabolics go out of control, then prior auth Lybalvi instead.

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I think that it's personally not worth the insurance hassle right now.  I had to get a prior auth for fanapt and the insurance company is shelling out an arm and a leg for it....around $1200/30 pills.  I only pay $75/month.  I can't imagine that they'll grant a prior auth for another medication that's an antipsychotic at the same time, although I can't go any higher on fanapt and still sleep at night.  I'll have to see if saphris takes away the residual AH. 

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50 minutes ago, dancesintherain said:

I think that it's personally not worth the insurance hassle right now.  I had to get a prior auth for fanapt and the insurance company is shelling out an arm and a leg for it....around $1200/30 pills.  I only pay $75/month.  I can't imagine that they'll grant a prior auth for another medication that's an antipsychotic at the same time, although I can't go any higher on fanapt and still sleep at night.  I'll have to see if saphris takes away the residual AH. 

Gotcha. Just thought I’d let you know about the copay card in case you didn’t know about it!

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1 hour ago, browri said:

Lybalvi will be a tricky one when it comes to insurance. It could go either way. Usually, when an old medication is reintroduced in a combo med, insurance companies rarely touch it if both medications can be given as generics. An example of this is Contrave which is a combination of 8mg naltrexone with 90mg of bupropion. They're sustained release tablets that need to be taken twice a day. For the bupropion component, you can take 100mg Wellbutrin SR twice a day, but naltrexone only comes in 50mg tablets that are scored once. If you split them into quarters you could get 12.5mg if you somehow managed to not destroy the tablet.

I guess what I'm getting at is that Contrave was an example of pharmaceutical evergreening, and the method was using doses of bupropion 90mg and naltrexone 8mg, which aren't available as generics, as well as using a controlled release, low-dose form of naltrexone that you can't find anywhere else on the market. However, insurance companies still choose not to cover it because both medications can be acquired in generic forms. I generally regard my insurance as being quite permissive (Premera Blue Cross), and they still don't cover Contrave.

With Lybalvi, the samidorphan component is technically a new chemical entity even though it is a modification of the naltrexone structure. The manufacturer may argue that samidorphan has greater bioavailability than naltrexone, but naltrexone is still only administered once a day. So inventing samidorphan was more about creating a new product that couldn't be reproduced with generic substitution.

Insurance companies will see right through this. The samidorphan component doesn't provide any additional efficacy according to trials. It just improves side effects. This is notable, however, because improving the side effects of olanzapine enough could be what's needed to make a more useful medication. Olanzapine is widely regarded as one of the most effective atypical antipsychotics (after clozapine), but in recent years, it has been relegated to second-line because of the exorbitant metabolic dysfunction. If insurance companies had it their way, more people would take olanzapine and clozapine because of their high efficacy, but then they would be stuck also paying out for metformin among other medications to keep metabolic dysfunction at bay. If there was a form of olanzapine that didn't trigger additional health issues, it may be worth paying for (although list price for Lybalvi looks to be ~$1300/30 tabs).

Just checked my own insurance and it's actual on-formulary as a non-preferred brand. Requires prior authorization, but the fact that it's even listed on the formulary as covered is surprising to me. Although it may prove my point above. Have the patient try olanzapine first. If their metabolics go out of control, then prior auth Lybalvi instead.

Ok. So. Riddle me this @browri. My insurance covers lybalvi. I am pondering talking to my NP about it.

I currently take the generic Zyprexa zydis. I am losing about 1-2 lbs a month. But I’d obviously like to lose more of the dang seroquel weight as fast as I can and get back to a healthy weight. I was wondering if I’d benefit from lybalvi?

I don’t understand though. Let’s say I was in a car accident and needed pain meds. Would the samidorphan make me not able to benefit from any pain med? Like if I needed it, it wouldn’t work because of the samidorphan I was taking? I just don’t understand what this medication is. Are there any downsides to taking samidorphan that I’m just not getting/understanding?

And thank you so much in advance. 

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27 minutes ago, Wonderful.Cheese said:

Ok. So. Riddle me this @browri. My insurance covers lybalvi. I am pondering talking to my NP about it.

I currently take the generic Zyprexa zydis. I am losing about 1-2 lbs a month. But I’d obviously like to lose more of the dang seroquel weight as fast as I can and get back to a healthy weight. I was wondering if I’d benefit from lybalvi?

I don’t understand though. Let’s say I was in a car accident and needed pain meds. Would the samidorphan make me not able to benefit from any pain med? Like if I needed it, it wouldn’t work because of the samidorphan I was taking? I just don’t understand what this medication is. Are there any downsides to taking samidorphan that I’m just not getting/understanding?

And thank you so much in advance. 

You're onto it. Because samidorphan is an opioid antagonist, it will block the effects of opioid agonist pain medication. However, it is worth noting that samidorphan has a half-life of ~7-9 hours. It would take time, but it would clear your system.

So in your car accident scenario, when the ambulance comes to take you to the hospital, if they try to give you pain meds, you'll likely still have samidorphan in your system and pain medication may not do much, or they'll have to use higher doses of stronger medications (think fentanyl/carfentanil/sufentanil or morphine in lieu of hydrocodone, oxycodone, hydromorphone) to treat your pain, at least initially. However, with samidorphan's short half-life, you would likely be able to take normal doses of standard pain medication after a time. By half-life, it would take just over 2 days for samidorphan to completely leave your system.

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On 4/3/2022 at 2:09 PM, browri said:

You're onto it. Because samidorphan is an opioid antagonist, it will block the effects of opioid agonist pain medication. However, it is worth noting that samidorphan has a half-life of ~7-9 hours. It would take time, but it would clear your system.

So in your car accident scenario, when the ambulance comes to take you to the hospital, if they try to give you pain meds, you'll likely still have samidorphan in your system and pain medication may not do much, or they'll have to use higher doses of stronger medications (think fentanyl/carfentanil/sufentanil or morphine in lieu of hydrocodone, oxycodone, hydromorphone) to treat your pain, at least initially. However, with samidorphan's short half-life, you would likely be able to take normal doses of standard pain medication after a time. By half-life, it would take just over 2 days for samidorphan to completely leave your system.

Thank you for the information! I will discuss with my dr. I don’t know if it’s worth it to switch to Lybalvi since I am losing weight (although slowly) on the zydis form of Zyprexa. Thank you thank you! 

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