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New Migraine Drug Telcagepant on Hold, Perhaps Permanently

telcagepant on holdTelcagepant, a migraine abortive with much success in clinical trials, is now on hold. It will not be submitted to the FDA for approval this year, as Merck previously announced. Originally studied for intermittent use, patients in an early trial to see if the drug could be used as a daily preventive developed high levels of liver enzymes.

The article doesn’t explain why, but here’s my take: People with frequent migraine episodes often take abortives more frequently than recommended. Even using telcagepant as an abortive, these patients could also develop high levels of liver enzymes.

The bad news for migraineurs is the findings could be significant enough to shelve the drug permanently. Merck, which was banking on the drug, can’t be too happy either.

What are your thoughts on why the drug is on hold?

12 Responses to New Migraine Drug Telcagepant on Hold, Perhaps Permanently

  1. Daniel Newby says:

    Blocking the CGRP receptor was thought to be extremely safe, to the point that telcagepant could plausibly have gone OTC for all types of headache within a few years.

    There are a lot of people abusing OTC drugs for headache and “sinus problems”. Such people get a lot of kidney and liver damage (from acetaminophen) and get a lot of dangerous ulcers (aspirin). The FDA could probably be convinced that getting people off Excedrin Sinus would have be a major benefit to public health. That would have given Merck a strong case for making telcagepant OTC, perhaps even if it had some significant side effects.

    And that is worth paying huge amounts of money to rush the trials and FDA reviews. Now that the OTC market is impossible, telcagepant is locked into being a niche prescription drug. That doesn’t mean it is doomed, just that Merck is not going to blow an extra $100M for crash priority trials. Unless the liver toxicity is severe, telcagepant is probably no worse than the existing drugs for refractory headache: valproate, the ergots, Midrin (contains chloral hydrate), and the neuroleptics. With restrictive labeling, there is a reasonable chance telcagepant is marketable.

    For the future, I suspect that the liver tox has nothing to do with CGRP. Telcagepant is a pretty low potency drug, which means they have to hit the CGRP receptor with massive doses. (The dose is something like 300 mg. A “good” drug would work down around 1 mg.) If the chemists can discover a new version that is 10 or a 100 times more potent, the liver problem will probably vanish. In fact, Merck might already have that improved drug in animal trials.

  2. No idea about the med itself, but actually there are no meds currently approved by the FDA as Migraine abortives nor any marketed by the drug manufacturers as abortives.

    They’re all identified as “treatments”.

    If the telcagepant folks (and I’m including all the research scientists not associated with Merck) were wanting to identify it as a Migraine abortive, don’t know if the FDA would approve it without evidence that in fact it aborts a migraine.

    Too, there are plenty of migraine treatment meds with far worse side effects than elevated liver enzymes so I wonder if that’s the cause of the delay?

    Even the triptans are not marketed or approved by the FDA as Migraine abortives, only as treatments.

    Just my 2 cents.

  3. Mary Kay says:

    Hi Kerrie,
    At our center we did do research a couple of years ago on another CGRP receptor blocker and the results were disappointing..it just didn’t work. I was initially happy at another drug within the class showing promise, but the FDA just won’t approve something that initally causes elevated liver enzymes and that is a good thing.

    Research studies are pretty well followed and patients generally can’t take more doses than what they are given..in other words they aren’t given a large supply of the drug to use. They also agree to document their results in a diary for headache response and blood work is taken at regular intervals throughout the study.

    There are other things on the horizen though..a patch form of the triptans, an inhalable form of DHE (ergot) and since Treximet was launched everyone is looking for the next new combo drug!

    Alot of interest right now on looking at low dose Cymbalta for migraine prevention. I will update you when I hear more..

  4. Mary Kay says:

    Hi Kerrie,
    Here is the latest update, straight from Merke. We met with their research people last week here at our clinic.

    According to Merke, they never wanted to position Telcagepant as daily therapy. The study that showed elevated enzymes was a daily therapy study.

    The company IS going ahead with Phase III trials, but looking at abortive therapy only. They did admit that they are going to do a retrospective look at all their studies on this drug and examine the issue of liver enzymes.

    I suspect the new trials will have more bloodwork for the the patients to do.

    Take care..hope the head is well.
    Mary Kay

  5. Evil Kitteh says:

    Im using cafergot to stop the migraine whenever it happens. What are you on?

  6. It would be a tragedy if this medication showing such great promise was not submitted for FDA approval. How it’s used should also be between the physician and their patients. Who it’s used with does need to be closely monitored and liver function tests should be a prescribing recommendation in my opinion.

  7. OK now it’s August 2009. My neuro told me at my last appointment which was a couple of weeks ago that Telcagepant will be out this year. Wondering if someone knows if that’s true.

  8. Lynne says:

    This is a big disappointment, as it sounded like an answer to my problems. Having had migraines for 40 years & a heart attack in 2003, I can no longer take Imitrex. I was holding out hope for Telgepant. I hope they reconsider. Like someone else said, almost everything you take has some side effects, but unless you have lived with migraines, no one can fully understand the debilitation of a migraine.

  9. Ryan says:

    I participated in the study for MK-0974 (Telcagepant) for prevention of headaches, and while I will admit that it did work slightly, it also gave me VERY aggressive tenancies- I would become explosive for no reason, when I am a calm person otherwise. I personally, was kind of happy that the study was stopped, as I did not like the side effects at all, but I was devoted to finishing the study. I have had a difficult time finding meds that work well, and I felt that a CGRP antagonist would be a great breakthrough if it worked. While the drug did slightly reduce my headaches, the side effects were too much to bear on a daily basis. I would not have continued the medication if given the oportunity to, after the study, for those reasons. I can only imagine how the “as-needed” crowd will have the same side effects. It’s to bad that Telcagepant isn’t working out, but possibly a different CGRP drug will in the future.

  10. Nancy Winlove-Smith says:

    Migraines? Have you tried acupuncture? My clients have tried it, ditched the meds and have not been back.

  11. Val says:

    I just got accepted into a clinical trial of Telecagepant, sponsored by Merck. It is a six month trial, with the drug (170 mg) being taken 7 days a month. They are asking us to begin taking it the first day of our cycle and continue for seven days. We are allowed to use pain-relieving drugs if a migraine does occur. I get menstrual (and non-menstrual) migraines- so this won’t eliminate all of them, even if it does work. I am skeptical because we don’t take the drug until the first day of our cycle and it’s not uncommon for me to get a helluva migraine the day BEFORE I start to bleed. It’s like a switch in my brain that goes off. So, the “good” news is- more research is being done on this drug.

  12. Al Winslow says:

    Dear Sirs,

    A group of independent researchers has come up with a hypothesis which targets the hepatic
    enzyme underlying migraine. We make the proposal
    that there is a missing piece in the migraine puzzle, and we think we can supply same. Can you suggest where this material could best be sent? The layman is far more savvy, sometimes, than the clinician, and we would like to put this reader-friendly material within reach of the public.

    Thank you,

    Al

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