New abuse resistant hydrocodone (Adapaz) approved by FDA

[RiteAidRockStar]

The FDA just approved a hydrocodone prodrug that cant be snorted/injected/smoked. If they try it's inactive in the blood stream. It needs to be activated by stomach enzymes.

I think this is going to be huge, especially if they allow it to be dispensed as a c3 instead of a C2.

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[BigBoss]

Sounds expensive. I can already imagine the headaches trying to get PAs approved.


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[RiteAidRockStar]

Worth it if it's a c3.

 

[lord999]

I'm waiting for an FDA panel that doesn't buy the corporate line. The most innovative people I ever met were addicts, nothing gets in the way of getting their high...

 

[RiteAidRockStar]

So this might be a stretch... but I just had a thought. My state doesn't require the orange book. It would be nice if we could just dispense this whenever we get a norco RX.

The company used previous hydrocodone studies instead of doing their own. They asked the FDA to assume bioequivalence based on their own studies. The FDA went for it as far as I can tell.

 

[RiteAidRockStar]

I'm waiting for an FDA panel that doesn't buy the corporate line. The most innovative people I ever met were addicts, nothing gets in the way of getting their high...

This one is different. The other abuse deterrents all just add something. The actual chemical structure is different for this one. They add a benzoate group and it requires a stomach enzyme to cleave it off.

 

[RiteAidRockStar]

Think back to Ochem. What will cleave off a benzoic acid derivative? There's nothing that comes to mind that won't hit another part of the molecule first.

 

[zelman]

This one is different. The other abuse deterrents all just add something. The actual chemical structure is different for this one. They add a benzoate group and it requires a stomach enzyme to cleave it off.

You think they won’t use vomit to access those enzymes?

 

[Lexington2012]

Vomit won't work. The enzymes needed are actually in the small intestine, not the stomach as OP mentioned. There's separation by a sphincter.

 

[Seriously Serious]

Do you have a reference? I'm not seeing any literature online.

 

[PharmDBro2017]

How did the assumption about being made a C3 come about?


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[Momus]

I'm waiting for an FDA panel that doesn't buy the corporate line. The most innovative people I ever met were addicts, nothing gets in the way of getting their high...

Just visit Bluelight - The Front Page. They will tell you how to get high on your drug of choice lol... Hell, you can make new friends to get high together there...

 

[Dr Wario]

So sales of Creon will go through the roof...

 

[BidingMyTime]

No ins is going to pay for this, certainly not Medicaid. The people with top of the line ins that will pay for this, are probably not the people who are abusing hydrocodone.

Also, I highly doubt this will be CIII, even if it is "tamper-proof".

 

[Abby Atwood]

I this drug is exciting, but insurance may be an issue. Medicaid may cover it with certain criteria. That could open the door for some use in at risk populations. Other insurance may cover with a high copay and possibly prior authorization. That creates an opportunity for access with manufacturers coupons. Medicare patients are probably out of luck; however, if it’s not a specialty drug, it may be eligible for a tier exception request.

I also don’t think it’s going to change to a CIII, and I’m not sure that we would want it to.

Criteria for CIII schedule:
“Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence.”

Even with the change in structure, I don’t think any opioid could be considered to have a moderate to low potential for physical or psychological dependence.

 

[zelman]

Even with the change in structure, I don’t think any opioid could be considered to have a moderate to low potential for physical or psychological dependence.

Don’t forget, tylenol with codeine is a C3/C5 (tabs/elixir).


And in terms of who will pay for this: probably just workers comp. they get stuck paying for the priciest garbage.

 

[Litha]

This makes me think of Vyvanse, which is also a pro-drug, and also a C-2. So I doubt Adapaz would be a C-3.

 

[Rouelle]

A couple of thoughts:

1. Drugs can be abused orally too, not just via injection/inhalation/smoking.

2. As a trained synthetic organic chemist, I’m pretty confident I could go into into a lab and selectively tease off a benzoate group. If I can do it in a lab, a resourceful addict will figure out how to do it at home.

 

[Abby Atwood]

Don’t forget, tylenol with codeine is a C3/C5 (tabs/elixir).


And in terms of who will pay for this: probably just workers comp. they get stuck paying for the priciest garbage.

True Technically codeine cough syrups are OTC in my state. I'm not sure if local pharmacies are actually selling stuff like that OTC though. Also true about the workers comp. We had a workers comp guy who would refuse any generic med. He even made his doctor resend some scripts that were originally written for generics.

 

[CetiAlphaFive]

The FDA just approved a hydrocodone prodrug that cant be snorted/injected/smoked. If they try it's inactive in the blood stream. It needs to be activated by stomach enzymes.

I think this is going to be huge, especially if they allow it to be dispensed as a c3 instead of a C2.

You guys really think your problem patients aren't going to make themselves barf, crush it, mix a little barf into the powder, then do snort the barf mix?

EDIT: I didn't read the thread. lol

 

[KennethCool]

This makes me think of Vyvanse, which is also a pro-drug, and also a C-2. So I doubt Adapaz would be a C-3.

That's probably because both Adapaz and Vyvanse were invented by the same chemist, Travis Mickle. He used to be the lead chemist at Shire. He left and took all the talent with him to the new company he created, KemPharm.

I've been VERY happy with the performance of KemPharm stock. It has gone up almost 400% since I bought it.

 

[txpharmguy]

Aren't Hysingla and Zohydro already abuse deterrent hyrdocodone?

 

[lord999]

A couple of thoughts:

1. Drugs can be abused orally too, not just via injection/inhalation/smoking.

2. As a trained synthetic organic chemist, I’m pretty confident I could go into into a lab and selectively tease off a benzoate group. If I can do it in a lab, a resourceful addict will figure out how to do it at home.

Is the manufacturer kidding us? Really?

Trivial with basic chemistry:
1. Modified Prevost esterification if you have the Iodine (a bit cheaty because it's List I).
2. Nitration with N2 and Cl2 gas/ultraviolet (non listed)

 

[Elle928]

The FDA already had a panel meeting for this and it initially ended up not getting approved. They concluded that it wasn't abuse deterrent. I'm not sure what the drug company changed to get approved but the label still says it's not abuse deterrent.
where is everyone reading that it can't be abused??