| Preos & Preotact (PTH)
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.
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