Current Scheduling Status
Year(s) and type of review / ECDD meetings
Drug Class
ECDD Recommendation
Inclusion in Schedule IV of the 1971 Convention on Psychotropic Substances
Recommendation (from TRS)
Substance identification
Aminorex (CAS 2207-50-3), chemically 2-amino-5-phenyl-2-oxazoline, is also known as aminoxaphen and aminoxafen; aminorex fumarate was
formerly marketed as Apiquel and Menocil. Aminorex has an asymmetric carbon atom, so two stereoisomeric forms and one racemate are possible.
WHO review history
In 1969, the 17th meeting (2) of the Committee recommended aminorex for international control in a group which is equivalent to Schedule IV of
the Convention on Psychotropic Substances, 1971. However, aminorex was not included in the original list of controlled substances when the 1971 Convention was adopted. In 1992, the 28th meeting of the Committee recommended critical review of aminorex.
Similarity to known substances and effects on the CNS
Aminorex is chemically similar to 4-methylaminorex,’ which has been classified in Schedule I of the Convention on Psychotropic Substances,
1971. Aminorex produces the characteristic effects of central nervous system stimulants like amfetamine, and has been used clinically for its anorectic effects. Its adverse effects are also similar to those produced by central nervous system stimulants. When used as an anoretic, however, aminorex is considered to have been responsible for a significant incidence of pulmonary hypertension. This led to its withdrawal from the market in 1968.
Dependence potential
In drug discrimination studies, aminorex generalizes to amfetamine and cocaine. Animal self-administration studies indicate that aminorex has some reinforcing effects and suggest that it has a moderate dependence potential.
Actual abuse and or/evidence of likelihood of abuse
Police and forensic reports indicate that aminorex is illicitly distributed in the USA as well as in Germany to a limited degree. Such reports document its distribution as amfetamine or metamfetamine, which suggests that the population using aminorex is primarily composed of stimulant abusers. In spite of the limited level of actual abuse, aminorex is assessed to have a moderate abuse liability in view of the simplicity of its manufacture in clandestine laboratories.
Therapeutic usefulness
Because of its serious adverse effects, aminorex is assessed to have very little, if any, therapeutic usefulness.
Recommendation
On the basis of the available data concerning its pharmacological and toxicological profile, dependence potential and likelihood of abuse, the public health and social problems associated with the abuse of aminorex are assessed to be significant. On the basis of this and the assessment of its therapeutic usefulness, it is recommended that aminorex be placed in Schedule IV of the Convention on Psychotropic Substances, 1971.
Aminorex (CAS 2207-50-3), chemically 2-amino-5-phenyl-2-oxazoline, is also known as aminoxaphen and aminoxafen; aminorex fumarate was
formerly marketed as Apiquel and Menocil. Aminorex has an asymmetric carbon atom, so two stereoisomeric forms and one racemate are possible.
WHO review history
In 1969, the 17th meeting (2) of the Committee recommended aminorex for international control in a group which is equivalent to Schedule IV of
the Convention on Psychotropic Substances, 1971. However, aminorex was not included in the original list of controlled substances when the 1971 Convention was adopted. In 1992, the 28th meeting of the Committee recommended critical review of aminorex.
Similarity to known substances and effects on the CNS
Aminorex is chemically similar to 4-methylaminorex,’ which has been classified in Schedule I of the Convention on Psychotropic Substances,
1971. Aminorex produces the characteristic effects of central nervous system stimulants like amfetamine, and has been used clinically for its anorectic effects. Its adverse effects are also similar to those produced by central nervous system stimulants. When used as an anoretic, however, aminorex is considered to have been responsible for a significant incidence of pulmonary hypertension. This led to its withdrawal from the market in 1968.
Dependence potential
In drug discrimination studies, aminorex generalizes to amfetamine and cocaine. Animal self-administration studies indicate that aminorex has some reinforcing effects and suggest that it has a moderate dependence potential.
Actual abuse and or/evidence of likelihood of abuse
Police and forensic reports indicate that aminorex is illicitly distributed in the USA as well as in Germany to a limited degree. Such reports document its distribution as amfetamine or metamfetamine, which suggests that the population using aminorex is primarily composed of stimulant abusers. In spite of the limited level of actual abuse, aminorex is assessed to have a moderate abuse liability in view of the simplicity of its manufacture in clandestine laboratories.
Therapeutic usefulness
Because of its serious adverse effects, aminorex is assessed to have very little, if any, therapeutic usefulness.
Recommendation
On the basis of the available data concerning its pharmacological and toxicological profile, dependence potential and likelihood of abuse, the public health and social problems associated with the abuse of aminorex are assessed to be significant. On the basis of this and the assessment of its therapeutic usefulness, it is recommended that aminorex be placed in Schedule IV of the Convention on Psychotropic Substances, 1971.
Link to full TRS
who_trs_856.pdf1.07 MB