Knoll Files Sibutramine NDA In USA

20 August 1995

Knoll Pharmaceuticals has filed a New Drug Application with the US Food and Drug Administration for sibutramine, the antiobesity drug acquired by Knoll's parent company BASF Pharma when it took over the pharmaceutical business of Boots in April. This is the second filing for the drug - in May, a dossier was submitted in the UK.

Knoll hopes to launch the product onto the US and European markets in 1997, and expects a quick take-up as sibutramine "has considerable advantages over conventional weight loss products," according to Thorlef Spickschen, head of BASF's pharmaceuticals division.

Sibutramine is a novel weight-modifying agent which exerts its actions predominantly through enhancing satiety and by raising metabolic rate, said a spokesperson for the company. The drug has serotonin and noradrenaline reuptake inhibition properties, and is thought to reduce food intake by enhancing central noradrenergic and serotonergic function, while stepping up the metabolic rate by raising peripheral noradrenergic function.

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