Ergo's Ergoset Not Worth The Risk Says FDA

Ergo's Ergoset Not Worth The Risk, Says FDA

T the US Food and Drug Administration has rejected the New Drug Application for Ergo Science's anti-diabetic Ergoset (bromocriptine mesylate). The Division of Metabolic and Endocrine Drug Products at the FDA felt that current studies indicated the product's risks may outweigh its benefits in patients with type 2 diabetes.

As a result, Ergo Science's shares fell $1.69 to $1.63. About 1.70 million shares were traded, more than 23 times the three-month daily average, according to Bloomberg News. Shares had traded as high as $18 per share a year ago, prior to May when a FDA advisory panel unanimously voted against recommending approval of Ergoset due to confusion over how the drug works and concern over the mechanism of action.