7 ms·

Doc here. I was at a continuing education course last year. FDA approved a new narcotic very fast. A non narcotic alternative is taking forever to approve. I

Doc here. I was at a continuing education course last year. FDA approved a new narcotic very fast. A non narcotic alternative is taking forever to approve. Its name is Maxigesic. Tylenol and ibuprofen in one pill. Why?

dickeytk 7y ago
What do you think the reason is? I only ask because there are (probably) few Doctors here and it's an interesting question.
- burpsnard 7y ago
  Yes.. fda approves combination pills seperate to each drug on it's own. While i'm not a pharmacologist, it dies seem odd
- acd10j 7y ago
  not a doctor, I for one will prefer a single pill instead of two pills , Swallowing pill is unpleasy for me, if there are too many pills , There is higher chance of mistakes (like forgetting, mixing doses etc) .I will pay a reasonable premium for one combination pill instead of two pills.
merpnderp 7y ago
That’s very strange. People have been alternating/mixing Tylenol and Ibuprofen for nearly 60 years. Don’t we know how they interact?
- Cougher 7y ago
  Yes we do. People see the equation as drug + drug = relief. Pharmaceutical companies see the equation as drug + drug + patent = $
- ensignavenger 7y ago
  I don't know about this drug, but they may be using a different manufacturing process or something else that is undergoing scrutiny.
qxnqd 7y ago
>Maxigesic. Tylenol and ibuprofen in one pill. What's the point of this, compared to just having half a pill of tylenol and half a pill of ibuprofen?
- iudqnolq 7y ago
  If anyone reads this for medical advice (and I really hope they wouldn't be taking advice directly from HN without any filtering), you don't combine them in equal proportions.
  - selectodude 7y ago
    Yes, you combine 500mg of acetaminophen and 150mg of ibuprofen. Ibuprofen only comes in 200mg pills, so if you want to be really spot on, take the liquid stuff for kids.
    - deleted 7y ago
      [deleted]
    - StuffedParrot 7y ago
      That seems pretty high for acetaminophen and low (proportionally) for ibuprofen. Why would you prescribe that?
      - iudqnolq 7y ago
        500mg is the max for ace a doctor is recommended to proscribe (on it's own). 150 is well below the max for ibu. Also I think you may have mixed up the grandparent commentator that stated they were a doctor and the parent that may be a doctor but hasn't made that claim here.
        GoodOldNe 7y ago
        Am doctor. Routinely prescribe 1000 mg of Acetaminophen.
wiggles_md 7y ago
Might have to do with the claims are they seeking for Maxigesic?
akiselev 7y ago
Clinical trials are complicated beasts. The simplest answer is likely that the CRO running the trials - at least I hope its a CRO - isn't set up to target the kind of patients/doctors needed for approval or they don't have funding immediately available to speed that process up at the necessary scale.
refurb 7y ago
What process is Maxigesic being approved under? I assume an aNDA, which is for generic drugs. The FDA has a massive backlog for generic drugs, while novel drugs (NDA) don’t.
- deleted 7y ago
  [deleted]
refurb 7y ago
As someone who works in the drug industry, when Maxigesic is approved, please don't prescribe it. Just tell your patients to take one each of the OTC drugs, they are dirt cheap (like $0.02 per pill). The market is full of drugs that are combinations of OTC medications and usually they are way more expensive. Even if they didn't go nuts with the price, why make a patient pay $0.50 per pill when they could take 2 for $0.04?
- qrbLPHiKpiux 7y ago
  That’s what I do now.
  - refurb 7y ago
    Good stuff. Lots of doctors don’t. Not out of bad will, but they just don’t have the time to dig into it.
- ensignavenger 7y ago
  Some patients have a lot of pills to take, and they would rather pay more to take fewer. Maybe they have trouble keeping track of them, maybe it is just pill fatigue. Maybe they have trouble swallowing for one reason or another. Combo pills could be a good thing for a subset of the population. Sure, it requires doctors to be on top of their game and patients to research what they are taking and ask questions, but that doesn't mean it isn't a good idea to have it available as an alternative. As to the question about why it is taking so long at the FDA, I imagine it isn't a very high priority because there are alternatives.
  - refurb 7y ago
    I don’t disagree that pill burden can be an issue. The problem is the lack of transparency into cost which results in some drug companies taking advantage. Combine two pills that cost $0.10 each into one pill that costs $0.15? Reasonable. Do the same and charge $5 per pill? Ridiculous. Problem is doctors and patients don’t know it costs $5 and insurers can’t be bothered to push back. Suddenly you’ve increased the cost of therapy by 50x.
shsidns 7y ago
If I had to take a guess it’s because drug A + B != AB The drugs in question could, combined have deleterious effects (say if their extortion mechanisms are the same). This shouldn’t be a problem because Tylenol + Advil has been done for decades. However, a beauricracy doesn’t see it as a solved problem to fast track unless there is a specific fast track for this exact scenario.

dickeytk 7y ago

What do you think the reason is? I only ask because there are (probably) few Doctors here and it's an interesting question.

burpsnard 7y ago
Yes.. fda approves combination pills seperate to each drug on it's own. While i'm not a pharmacologist, it dies seem odd
acd10j 7y ago
not a doctor, I for one will prefer a single pill instead of two pills , Swallowing pill is unpleasy for me, if there are too many pills , There is higher chance of mistakes (like forgetting, mixing doses etc) .I will pay a reasonable premium for one combination pill instead of two pills.

merpnderp 7y ago

That’s very strange. People have been alternating/mixing Tylenol and Ibuprofen for nearly 60 years. Don’t we know how they interact?

Cougher 7y ago
Yes we do. People see the equation as drug + drug = relief. Pharmaceutical companies see the equation as drug + drug + patent = $
ensignavenger 7y ago
I don't know about this drug, but they may be using a different manufacturing process or something else that is undergoing scrutiny.

qxnqd 7y ago

>Maxigesic. Tylenol and ibuprofen in one pill. What's the point of this, compared to just having half a pill of tylenol and half a pill of ibuprofen?

iudqnolq 7y ago
If anyone reads this for medical advice (and I really hope they wouldn't be taking advice directly from HN without any filtering), you don't combine them in equal proportions.
- selectodude 7y ago
  Yes, you combine 500mg of acetaminophen and 150mg of ibuprofen. Ibuprofen only comes in 200mg pills, so if you want to be really spot on, take the liquid stuff for kids.
  - deleted 7y ago
    [deleted]
  - StuffedParrot 7y ago
    That seems pretty high for acetaminophen and low (proportionally) for ibuprofen. Why would you prescribe that?
    - iudqnolq 7y ago
      500mg is the max for ace a doctor is recommended to proscribe (on it's own). 150 is well below the max for ibu. Also I think you may have mixed up the grandparent commentator that stated they were a doctor and the parent that may be a doctor but hasn't made that claim here.
      - GoodOldNe 7y ago
        Am doctor. Routinely prescribe 1000 mg of Acetaminophen.

wiggles_md 7y ago

Might have to do with the claims are they seeking for Maxigesic?

akiselev 7y ago

Clinical trials are complicated beasts. The simplest answer is likely that the CRO running the trials - at least I hope its a CRO - isn't set up to target the kind of patients/doctors needed for approval or they don't have funding immediately available to speed that process up at the necessary scale.

refurb 7y ago

What process is Maxigesic being approved under? I assume an aNDA, which is for generic drugs. The FDA has a massive backlog for generic drugs, while novel drugs (NDA) don’t.

deleted 7y ago
[deleted]

refurb 7y ago

As someone who works in the drug industry, when Maxigesic is approved, please don't prescribe it. Just tell your patients to take one each of the OTC drugs, they are dirt cheap (like $0.02 per pill). The market is full of drugs that are combinations of OTC medications and usually they are way more expensive. Even if they didn't go nuts with the price, why make a patient pay $0.50 per pill when they could take 2 for $0.04?

qrbLPHiKpiux 7y ago
That’s what I do now.
- refurb 7y ago
  Good stuff. Lots of doctors don’t. Not out of bad will, but they just don’t have the time to dig into it.
ensignavenger 7y ago
Some patients have a lot of pills to take, and they would rather pay more to take fewer. Maybe they have trouble keeping track of them, maybe it is just pill fatigue. Maybe they have trouble swallowing for one reason or another. Combo pills could be a good thing for a subset of the population. Sure, it requires doctors to be on top of their game and patients to research what they are taking and ask questions, but that doesn't mean it isn't a good idea to have it available as an alternative. As to the question about why it is taking so long at the FDA, I imagine it isn't a very high priority because there are alternatives.
- refurb 7y ago
  I don’t disagree that pill burden can be an issue. The problem is the lack of transparency into cost which results in some drug companies taking advantage. Combine two pills that cost $0.10 each into one pill that costs $0.15? Reasonable. Do the same and charge $5 per pill? Ridiculous. Problem is doctors and patients don’t know it costs $5 and insurers can’t be bothered to push back. Suddenly you’ve increased the cost of therapy by 50x.

shsidns 7y ago

If I had to take a guess it’s because drug A + B != AB The drugs in question could, combined have deleterious effects (say if their extortion mechanisms are the same). This shouldn’t be a problem because Tylenol + Advil has been done for decades. However, a beauricracy doesn’t see it as a solved problem to fast track unless there is a specific fast track for this exact scenario.