Less than two weeks after U.S. drug regulators raised serious doubts [1] about the safety of bremelanotide for ED, King Pharmaceuticals has decided to drop out of its co-development pact with Palatin Technologies. Regulators raised red flags on the therapy, noting an increase in blood pressure as a serious safety issue for patients that should prevent a late-stage study.
"Regarding the FSD program with bremelanotide, we have completed an exploratory at-home Phase II clinical trial in pre- and postmenopausal women and are in the final stages of compiling the data. We anticipate releasing the results later this month," stated Dr Carl Spana, CEO of Palatin. Palatin is also working a development program [2] for an obesity drug in a program paired with AstraZeneca.
- see the release [3]
- read this report [4] from DrugResearcher
Related Articles:
Safety concerns force delay for Phase III ED trial. Report [1]
Palatin researchers tout data. Report [5]
Gene therapy approach may work against ED. Report [6]
Links:
[1] http://www.fiercebiotech.com/story/safety-concerns-force-delay-phase-iii-ed-trial/2007-08-30
[2] http://www.fiercebiotech.com/story/astrazeneca-inks-two-pacts-worth-831m/2007-01-31?utm_source=related&utm_medium=internal
[3] http://www.fiercebiotech.com/press-releases/press-release-palatin-technologies-announces-reacquisition-full-rights-bremelanotide-
[4] http://www.drugresearcher.com/news/ng.asp?n=79626-king-pharmaceuticals-palatin-technologies-erectile-dysfunction-bremelanotide
[5] http://www.fiercebiotech.com/story/palatin-researchers-tout-sexual-dysfunction-data/2006-08-03
[6] http://www.fiercebioresearcher.com/story/gene-therapy-approach-may-work-against-ed/2007-06-05