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                  <text>November 29, 1968

Dr. Thomas V. Ksicher, M.D.
Geigy Pharmaceuticals
Ardslcy, New York

last

Dr. Koichct,

I hsvs read the material submittcd regarding GP 41299 with
bclicvs that we can participate in a number of studies
interact,
consistont with your goals of establishing tho potsncy and clinical
safety of this compound as a hypnotic and/or a minor tranquillizcr.
As we review the available dots. the compound hss been touted primarily
as a hypnotic and no effort is described to ascertain its other possible
and

activities.
like to

Thres types of studies are suggested, and whilc one would

rcccumcnd each of then, neither time not
personnel would permit this to he demo.

1.

EEG

profils analysis:

The EEG

available stuff

profile of

GP

41299 can

in volunteer subjects, on single oral trials. and the
spectra can be compared to a standard sedative (snobsrbitsl or
diatopcm) and to other compounds as imipramino. fsnflursminc sod
chlorpromszﬁnc. to ascertain its clinical similarity to thesc agents
at the dosages tested.

be soscsscd

2. Comparison with chlordistopoxido in the therapy of
clinical anxiety: The use of ODE as a standard in s mantcl health
clinic population has become accepted, and as hsvs undertaken studios
of other minor tranquillizsrs in comparison with this compound. A
similar study of GP 41299 should be considorsd.
3. Soporific activity in opiate withdrawal: Patients
withdrawn from opiates with methadone complain of severe insomnia.
The standard procedure is to ndoinistsr oothyprylou (Rolodex) and
this is generally acceptable. we would suggest the direct comoariscn
of mothyptylon and GP 41299 in a random sequoncs, for 3~S nights.
Acceptance by this population would icdiccts s high dcgrcc of soporific

activity.

would be pleased to undertskc any of those studies, with
study as the most profitable for you «w the study that may
add materially to your analysis of this novel compound. May I suggest
that you call my office and visit with on on December 10-12, December 16
or December 23. Unfortunstcly, I will be out of my office at the other
timss in the next tow weeks.

the

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information.

November 29, 1968

for the opportunity of tevicwing this interesting

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Sincarely yours,

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Fink, M.D.
Frofeusor af Psyehiatty

Max

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In ch¢ sweat that an EEG study is of intﬂtiﬂt, I would also
recannnnd that parallal atudiau be undertaken ta determine the
affects of GP 41299 on the 'alaap«print' -« the eomputer analysis
of the allwnight sleep E36. Tia techniquas available in this
country provide more quantitative information than reflected in the
summary from Dr. Carma, ané allow a more definitiva claauificgcion
of I ate compound and its coapnrison with established alaepvproducing
agonca in quantitativn terms.
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