Telcagepant, 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?
The FDA has approved production of topiramate, the generic version of migraine preventive drug Topamax. It will be available in multiple strengths from 17 different manufacturers.
This is great news for the many people who have found relief from migraines or headaches with Topamax. Except for the side effects, which many find intolerable, Topamax is often called as a “miracle drug.” I don’t believe in miracle drugs, but one that can help so many people is pretty impressive.
Ortho-McNeil Neurologic’s patents on Topamax began expiring last year.
[via Somebody Heal Me
Trexima, a combination of sumatriptan (Imitrex) and naproxen sodium (found in Aleve and other NSAIDs), was expected to receive FDA approval last week. Requesting more safety data, the FDA has delayed approval of Trexima.
The concern is about one of the four tests of genotoxicity, which is toxicity to DNA. The requested data are available from a study that has already been conducted. The FDA will meet with Pozen and GSK soon to discuss additional requirements.
“Potheads and Sudafed,” a NY Times editorial that ran yesterday, caught the attention (and raised the ire) of About.com’s headache page guide, Teri Robert. The article addresses issues raised by the FDA’s denial of medicinal marjiuana’s efficacy. Columnist John Tierney writes of the conundrum:
Officially, the D.E.A. says it wants patients to get the best medicine. But look at what it’s done to scientists trying to study medical marijuana. They’ve gotten approval for their experiments from the F.D.A., but they can’t get the high-quality marijuana they need because the D.E.A. won’t allow it to be grown. The F.D.A. actually wants to know if the drug works, but the D.E.A. is following the just-say-know-nothing strategy: as long as researchers can’t study marijuana, they can’t come up with evidence that it’s effective.
And as long as there’s no conclusive evidence that medical marijuana works, the D.E.A. and its allies on Capitol Hill can go on blindly fighting it. Representative Mark Souder, the Indiana Republican who’s the most rabid drug warrior in Congress, has been pressuring the F.D.A. to crack down on medical marijuana. Last week the agency finally relented: in return for not having to start busting anyone, it issued a statement stressing the potential dangers and lack of extensive clinical trials establishing medical marijuana’s effectiveness.
For more information about the DEA’s stance, see this post.
FYI: The article is only available on the Times site if you have a paid subscription, but you can probably use your public library card to read it in a full-text newspaper database online. (The database I used is called ProQuest and I accessed it trhough the magazine and newspaper section of the library’s databases. These specific details are only applicable through my library, of course, but I hope they help you navigate your library’s website.)
Yesterday the FDA announced that “no scientific studies” support the efficacy of medicinal marijuana. This statement contradicts the conclusions of a review from the Institute of Medicine, the country’s most prestigous scientific advisory agency. A review that concluded that marijuana is ‘moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting.’
Extrapolating from this, it’s an effective treatment for the nausea and vomiting that can accompany migraine. Anecdotally it also alleviates chronic pain.
My blood is boiling. Political ideology vilifies a drug that’s less
harmful than much of what we take to control pain. It can also cause less impairment than some patients experience with opioids.
Scientific data is the crux of the debate. Factions against medicinal marijuana say that no good scientific data exists to support it’s use. Proponents argue that the strict regulations on researching marijuana’s medical use make it impossible to engage in the clinical trials required to develop said scientific data.
The NY Times article examines both sides of the debate. I admit that it’s biased toward my view, but I think it makes a good argument. Unfortunately, the man in the picture that accompanies the story looks more like he’s at a smoky bar, enjoying a good high. Thus illustrating that artistic photography can undermine a well-presented argument.
Update, 10:14 a.m.: Typepad, the blogging tool that I use, creates a post’s permanent URL from the title of the post. For this post, it’s “fda_takes_on_me.” If only I wielded that much power.