Apomorphine-Subcutaneous — Bertek/Britannia
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Bertek Pharmaceuticals, a subsidiary of Mylan Laboratories Inc., is developing an intermittent subcutaneous formulation of apomorphine hydrochloride as a treatment for Parkinson’s disease. Apomorphine injection (APO-go®) for the treatment of Parkinson’s disease was launched in the UK in May 2002.
Bertek licensed the formulation from Britannia Pharmaceuticals in the UK for development and marketing in the US.
In April 2004, apomorphine injection was approved as the first and only therapy in the US for the acute, intermittent treatment of hypomobility, ‘off’ episodes associated with advanced Parkinson’s disease. This approval follows the fast-track status designation given by the US FDA in January 2003, and an approvable letter issued in July 2003. The product is expected to be available by July 2004.
KeywordsApomorphine Motor Score Efficacy Parameter Approvable Letter Unify Parkinson Disease Rate Scale
- 2.Koller W, APO-303 Investigators. A double-blind placebo-controlled study of the efficacy of a single dose of subcutaneous apomorphine in advanced Parkinson’s disease. Neurology 62 (Suppl. 5): 329 (plus poster) abstr. P04.135, No. 7, 28 Apr 2004Google Scholar