PikaB
03-22-2007, 09:43 PM
Saw a news item on Preotact, so I did a little web checking. It's a parathyroid hormone (PTH), injected like Forteo, and approved in the European Union countries. The main advantages (compared to Forteo):
(a) No two-year time limit, no black box warning;
(b) The pen can be out of the refrigerator for up to 7 (of the 28) days (so no hassle with trips);
(c) Although the active pen and cartridge should be refrigerated, a cartridge does not need to be refrigerated until activated in the pen, which means that the drug does not need to be refrigerated during shipping. (Unlike Forteo, which uses a separate pen each month, Preotact only uses one pen, and each month a new cartridge is inserted into the pen.)
Preos is the name it will (hopefully) be marketed under in the USA, but it has at least one more hurdle to clear before it will get FDA approval. NPS Pharmaceuticals recently stated:
"After multiple communications with the FDA, the company received feedback from the agency this week which NPS believes finalizes the protocol design and provides a clear direction for completing the development of PREOS in osteoporosis. This 12-month bone-mineral density bridging study is designed to evaluate the relative efficacy and safety of PTH (100 micrograms every other day, 100 micrograms daily, and 75 micrograms daily) versus placebo in post-menopausal women with osteoporosis."
So there is at least another year to go before Preos will be available in the USA.
(a) No two-year time limit, no black box warning;
(b) The pen can be out of the refrigerator for up to 7 (of the 28) days (so no hassle with trips);
(c) Although the active pen and cartridge should be refrigerated, a cartridge does not need to be refrigerated until activated in the pen, which means that the drug does not need to be refrigerated during shipping. (Unlike Forteo, which uses a separate pen each month, Preotact only uses one pen, and each month a new cartridge is inserted into the pen.)
Preos is the name it will (hopefully) be marketed under in the USA, but it has at least one more hurdle to clear before it will get FDA approval. NPS Pharmaceuticals recently stated:
"After multiple communications with the FDA, the company received feedback from the agency this week which NPS believes finalizes the protocol design and provides a clear direction for completing the development of PREOS in osteoporosis. This 12-month bone-mineral density bridging study is designed to evaluate the relative efficacy and safety of PTH (100 micrograms every other day, 100 micrograms daily, and 75 micrograms daily) versus placebo in post-menopausal women with osteoporosis."
So there is at least another year to go before Preos will be available in the USA.
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trail
03-23-2007, 06:20 PM
Pika B
Is this only for people who haven't taken Forteo, or can it be after? What are the differences and why is there no black box warning, refridgeration issues, etc.? I am going to look on the web and ask my doctor about it at our next visit. Thanks for the heads up.
Trail
Is this only for people who haven't taken Forteo, or can it be after? What are the differences and why is there no black box warning, refridgeration issues, etc.? I am going to look on the web and ask my doctor about it at our next visit. Thanks for the heads up.
Trail
taape
03-24-2007, 03:42 AM
I've got the same questions as Trail. I hope the FDA approves this and it can be for anyone with osteoporosis and especially those of us who can't tolerate the other medications.
I also know of a USA clinical trial for PTH in a patch although I don't qualify for the study. I thought this would be a good option because it only involves putting on a patch for 20 minutes per day then taking it off, no mess with the needles, etc.,
I also know of a USA clinical trial for PTH in a patch although I don't qualify for the study. I thought this would be a good option because it only involves putting on a patch for 20 minutes per day then taking it off, no mess with the needles, etc.,
PikaB
03-24-2007, 09:42 AM
I have no answers to your questions.
It seems logical that the differences in chemical composition accounts for the storage difference, and that the testing resutls (thus far) has not revealed anything similar to the results that prompted the black box warning for Forteo.
As for whether Preos/Preotact can be safely taken after 2 years of Forteo, it will probably be many years before there is a definitive answer.
Don't expect a USA doctor to be able to answer you questions about Preos/Preotact; most doctors are busy trying to keep up with information on the drugs that are available.
It seems logical that the differences in chemical composition accounts for the storage difference, and that the testing resutls (thus far) has not revealed anything similar to the results that prompted the black box warning for Forteo.
As for whether Preos/Preotact can be safely taken after 2 years of Forteo, it will probably be many years before there is a definitive answer.
Don't expect a USA doctor to be able to answer you questions about Preos/Preotact; most doctors are busy trying to keep up with information on the drugs that are available.