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Nystatin - LiposomalAR 121, Nyotran®

 

作者: &NA;,  

 

期刊: Drugs in R & D  (ADIS Available online 1999)
卷期: Volume 1, issue 2  

页码: 181-183

 

ISSN:1174-5886

 

年代: 1999

 

出版商: ADIS

 

数据来源: ADIS

 

摘要:

&NA;Liposomal nystatin (AR 121, Nyotran®) is a lipid-based intravenous formulation of nystatin that is being developed by Aronex. Phase III trials comparing liposomal nystatin to standard amphotericin B treatment in immunocompromised cancer patients with suspected systemic fungal infections are underway in Europe and the US. A phase III study in patients with Cryptococcal meningitis is also underway, and a phase II trial in non-neutropenic patients with candidaemia has been completed in the US. Together with development partner Grupo Ferrer, Aronex has submitted a Marketing Authorisation Application in Portugal and Spain and expects to file for registration in other European countries in 1998. The company also plans to submit a US new drug application for this indication in 1999. Liposomal nystatin appears to have antiviral activity and is under phase II development for the treatment of HIV infection.Aronex Pharmaceuticals have signed a licensing agreement with Abbott Laboratories for worldwide rights to Nyotran®. Under this agreement, Abbott will provide funding for the clinical development of the drug, will market it after it is approved and will be responsible for its registration in countries outside the USA. Aronex will be able to copromote Nyotran® in Canada and the US for at least 2 years.Nystatin is a tetraene-diene polyene antibiotic complex that is widely established as an antifungal agent. It has been used as an oral and topical antifungal agent but was too toxic to use intravenously. This liposomal formulation is less toxic.

 

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