I've long believed that there are at least some homeopathic remedies that actually work, against a range of conditions and diseases. It would seem that Whitehouse Station is (becoming) a believer, as well.
The long term problem has been -- as to the homeopathics -- that they generally lack the rigorous study data FDA requires to make an allergy-relieving/health care labeling claim. Once again, it seems that Merck is looking to change that -- at least as to ragweed antigens, and grass antigens. [It will in part cannibalize the OTC versions of Claritin®, etc. -- I guess.]
While Merck is pitching it as an alternative to allergy shots (in doctors' offices), as well, it will also have to go head to head with numerous (generally low-priced) homeopathic pills and capsules. I'll be curious to see whether the study data will support "pharmaceutical-grade" as a pricing differentiator.
Merck posseses, by license, the North American rights to a new ragweed-antigen based daily oral drug candidate developed by ALK-Abelló. It has shown moderately positive results, at least as compared to a placebo, in a Phase III trial. These studies were just reported at a conference in Orlando, Florida this weekend.
From Reuters, this morning -- just a bit -- do go read it all:
. . . .Merck & Co on Sunday said it would seek U.S. approvals next year for separate allergy pills that help tame the immune system's reaction to ragweed and grass, and the drugmaker released favorable data from a late-stage trial of the ragweed medicine.
The pills are meant to be an alternative to traditional allergy shots given in doctors' offices, which include a mixture of proteins that gradually weaken the immune system's response to ragweed, grass, foods and other allergy triggers.
The Phase III study involved 565 patients 18 to 50 years old prone to ragweed-induced allergies, with or without asthma. Patients took Merck's once-daily tablet for 52 weeks, at one of two available doses, or took placebos.
The active ingredient of the pill is Ambrosia artemisifolia, the chemical name of the ragweed allergen, or protein, that causes runny noses, sneezing and other miseries for millions of Americans. . . .
Specifically, the pill reduced allergy symptoms during peak ragweed season by 17 percent and 14 percent, respectively, at the higher and lower doses. . . .
The studies will support the thesis, no doubt -- but will they be enough to push the homeopathics to the side -- or will Merck's spend on an FDA approval backfire, and bolster demand for the homeopathics (many of which contain the very same active ingredient)? Only time will tell. At least Merck is looking everywhere, for new revenue, it seems.
7 comments:
As someone who suffers terribly every August like clockwork without medication, if the Merck solution would need to be taken year round (as it sounds the study was designed) I would not be interested in the therapy. I can now take Claritin for just a few weeks and be comfortable enough during the ragweed season. The expense of year round therapy and needing to dose during the off season wouldn't be worth it to me.
It is, however, interesting that Merck is taking this route.
This was a legacy S/P program. While it is with crude extracts, it really isn't a homeopathic medicine and the FDA isn't not treating it as such. Rather, the FDA is requiring rigorous studies along the lines of vaccines.
Oh, I agree, Anon. No. 2 --
In order to clear FDA, real science will be required, and yesterday's Orlando conference release suggests Merck will have the solid data by 2013 to seek approval for the antigen pill, with a labeled-allergy benefit, i.e., a pharmaceutical (making US market entry likely an early 2014 event).
My question is whether the money spent on gaining that approval will actually beenefit the homeopathics -- like a rising tide, lifting all the boats in the harbor.
And, Anon. No. 1 -- I do think your point is well-taken. If I understand Merck's intended positioning, though, they will sell it as an alternative to in-office allergy shots, at the doctor -- so the intended US market (at leat in Merck's view) may be more severely-afflicted allergy sufferers than you seem to suggest you are.
We shall see. Thanks to you both, and do stop back!
Namaste
PS: I'verevised the text of the post to make clear which meds go generic in 2012.
Condor,
thanks for your response. I would agree having this type of medicine would 'bump up' the homeopathics but your learned readers should remember the difference:
http://en.wikipedia.org/wiki/Homeopathy
BTW; as these aren't the only types of allergen clinical trials. For example:
http://www.clinicaltrials.gov/ct2/show/NCT00815035?term=peanut+allergy&rank=1
A news tidbit:
http://abcnews.go.com/Business/wireStory/merck-fda-combo-cholesterol-drug-now-15849296
Zetia with Lipitor-denied at this moment.
We communicated over this awhile back. You called it!
I think that the development program for this oral immunotherapy treatment - Merck has a ragweed tablet, grass tablet and house dust mite tablet - will address the unmet need in the TREATMENT of seasonal/perennial allergies due to these allergens. Unlike the symptom-relieving products like Claritin, Nasonex, etc. these tablets address the underlying cause of the allergies. So, they aren't just an alternative to immunotherapy shots, since there are many patients that don't want a shot treatment due to needle fears and treatment adherence of many office visits. These tablets are like a "vaccine" to treat the allergies and then the consumer won't suffer from the allergens in future years.
WHile I agree with everything you've written, latest Anon. commenter, I think the question is whether legacy Schering-Plough, now New Merck will be able to command a "pharmaceutical grade" price for the pills.
Homeopathic ones litter the shelves, at what I assume will be a much lower price than Merck will be hoping to command. And it is still true that a "vaccine" against allergies will cannibalize the Claritin/Clarinex sales.
Very good observations, here -- one and all! Do stop back!
Namaste
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