Mifegyne®

Mifegyne® in Australia and New Zealand

The use of Mifegyne® in New Zealand is approved for four indications:

  1. early medical abortion
  2. priming the cervix before surgical abortion
  3. second trimester medical abortion and
  4. induction of labour for fetal death in utero.

For the full Mifegyne® Medsafe Data Sheet – click here

HISTORY OF MIFEPRISTONE IN FRANCE AND EUROPE

RU486 was first synthesised in France by Roussel-Uclaf in 1980. In 1985 Bygdeman in Sweden reported that the drug was more successful when followed by a prostaglandin to stimulate uterine contractions. After clinical trials RU486 was registered for use in France as an abortifacient in September 1988.

In October 1988 because of pressure from anti-abortionists, Roussel-Uclaf decided to cancel distribution but there was a counter-protest by 2000 international O&G specialists attending a meeting in Rio de Janeiro, Brazil. Also present was Professor Baulieu, the French scientist responsible for the development of the drug.

Two days later on 28 October 1988 French Health Minister, Claude Evin, ordered that the drug be made available as the ‘moral property of women’.

In August 1997 the commercial rights were transferred to Exelgyn, a small French Company founded by Dr Edouard Sakiz, ex-Roussel-Uclaf.

In 1991 Mifegyne® was approved for use in the UK and in 1992 in Sweden. In 1999 it was approved in nine EEC countries and since then it has been approved in many other countries. New Zealand was the 22nd country to approve Mifegyne®.

HISTORY OF MIFEPRISTONE WORLDWIDE

In 1985 China conducted clinical trials and became the first country to approve the use of mifepristone. China manufactures its own RU486 and also supplies the USA market, through Danco Laboratories.

In 1983 the FDA issued a testing permit to the Population Council, a not-for-profit NGO established in 1952 and based in New York. In 1989 President Bush banned importation and in 1993 President Clinton reversed the ban. In May 1994 Roussel-Uclaf donated the patent rights for the USA to the Population Council. Clinical trials were conducted in 1995 and in September 2000 Mifeprex® was approved for use in early medical abortion.

In Australia in 1994 RU486 was used in clinical trials but in May 1996 Senator Brian Harradine introduced a restrictive measure which curtailed further use. This was reversed by a law change in February 2006. Use is now by approved prescribers.

In January 2008 Concept Foundation, an organisation promoting affordable healthcare in developing countries, announced the approval of Medabon® in Nepal. This is a low-cost combipack of mifepristone (oral) and misoprostol (vaginal). Regulatory approval is now being sought for use in other countries. Priority is given to the prevention of unsafe abortions in developing countries.