Safety concerns force delay for Phase III ED trial
With regulators at the FDA waving a red flag over safety concerns, King Pharmaceuticals and Palatin Technologies announced that they will delay the planned launch of a Phase III trial of bremelanotide for ED. Regulators said they were concerned by data in Phase I and Phase II that the drug raised patients' blood pressure in certain patients. Researchers had hoped to pursue the use of the drug as a first-line therapy, but the FDA says the best approach may be for use among patients who have not responded well to other, marketed ED drugs.
- check out the release
- read the MarketWatch report on the trial
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Comments
By Meghan | Posted 2:35pm | August 30, 2007
..and yet Viagra, which has sent some users to hospital emergency rooms and apparently even caused blindness, has FDA approval... It's all well and good that the FDA are considering allowing Bremelanotide to be used for men who don't respond to Viagra and Cialis and the like, but what about women patients who have shown a good response in Bremelanotide trials..? Women experiencing FSAD (due to cancer treatments and menopause, among other reasons) don't have any other options available to them right now.
By SY | Posted 9:45pm | August 30, 2007
I've not seen the data, but the FDA seems to be doing a subgroup analysis. That is difficult enough in Phase III, almost impossible in smaller Phase I and II. Even if true, it might well be sorted out in Phase III.
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