Galanthamine Enters Ph III In USA For Alzheimer's

UK company Shire Pharmaceuticals has reported that its developmental drug for the treatment of Alzheimer's disease, Reminyl (galanthamine hydrobromide), has moved into Phase III clinical trials in the USA. The study is being undertaken by Johnson & Johnson's Belgian subsidiary, Janssen Pharmaceutica NV, which is acting as Shire's codevelopment and licensing partner for the drug.

Enrollment of patients into the US study has already begun, according to Shire, which is itself conducting a Phase III trial of the drug in Europe. Updating on the status of this trial, Shire noted that recruitment of the 500-patient target population is complete, and results should be available in mid-1997. The company expects to file for approval "in the next 36 months or earlier."

Galanthamine is among a series of second-generation acetylcholinesterase inhibitors which are hoping to improve upon the performance of Warner-Lambert's Cognex (tacrine), which has toxicity problems and which provides symptom benefits for between nine and 18 months. It is hoped that galanthamine and other new drugs will provide greater tolerability and a longer duration of action than tacrine, and that this will translate to greater therapeutic efficacy.