FDA approves IND application from Addrenex Pharmaceuticals for new targeted therapy for hypertension
Wednesday, November 19 2008 | Comments
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Addrenex Pharmaceuticals Inc. received approval from the Food and Drug Administration for its Investigational New Drug Application for a novel hypertensive drug known as ADX415, and the company launched a Phase II clinical trial of the drug as a targeted therapy for hypertension.The double-blind, placebo-controlled, dose-ranging study will involve 80 patients.
ADX415 is a proprietary centrally acting, alpha-adrenergic receptor agonist specific to alpha-2 receptors. It was identified from a library of alpha-2 adrenergic compounds which the company licensed from the University of Nebraska Medical Center and that originated from Procter & Gamble Pharmaceuticals Inc.
"Numerous medical conditions arise from an overactive adrenergic nervous system, yet few drugs are available that specifically target this complex pathway," said Moise Khayrallah, Addrenex's chief executive officer.
"Our scientific team continues to identify and analyze alpha-2 compounds that could potentially address the unmet needs of patients across a wide range of conditions," Khayrallah added.
Addrenex submitted a New Drug Application to the FDA for its CloniBID (clonidine hydrochloride) to treat hypertension in February, and the company expects the agency to complete its review by the end of the year. Commercial rights to both drugs have been granted to Sciele Pharma Inc.
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