I am sure someone else saw this and will post it, but to be sure here is my
copy. Melatonin may be pulled as an over-the-counter-drug. Just a few
comments. The researcher is trying to find a small corner in which the use
of melatonin can be claimed a prescription drug. In this case, he is looking
at those who have insomnia, . Once he is able to get the drug declared a
prescription medicine for some disease, the drug will have to be pulled off
the health food store counters. Then he is free to really make big bucks.
You judge for yourself.
Regards,
Alan
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LEXINGTON, Mass.--(BUSINESS WIRE)--July 20, 1995--Findings presented
before the British Association for Psychopharmacology indicate that the
administration of low doses of melatonin, under development in the U.S. by
Interneuron Pharmaceuticals, Inc. (NASDAQ: IPIC) as a prescription drug
treatment for insomnia, can reduce the time required to fall asleep and
improve the quality of sleep.
The double-blind, placebo controlled cross-over study was conducted by a
team of researchers in the United Kingdom led by Dr. Philip Cowen. Subjects
were given two doses (.3 mg and 1.0 mg) of melatonin and placebo on three
different nights over several weeks. Home-based monitoring methods were
used to measure, in a natural setting, the time it took subjects to fall
asleep and the quality of their sleep. The researchers found that both doses
of melatonin reduced the time it took the subjects to fall asleep, increased
their actual sleep time, increased quality of sleep as reflected in deep or
"slow-wave" sleep, increased sleep efficiency as measured by the percentage
of time in bed spent sleeping, and reduced the number of awakenings after
the onset of sleep.
"This study supports the hypothesis that the administration of melatonin
at low doses has hypnotic effects, and unlike most currently available sleep
aids, may improve sleep quality," said Glenn L. Cooper, M.D., president and
chief executive officer of Interneuron. "These findings also support our
strategy of developing low-dose melatonin as a patent-protected,
prescription therapy for patients with insomnia.
"This study complements earlier pilot studies conducted at the
Massachusetts Institute of Technology by a team of researchers led by
Interneuron scientific founder Richard J. Wurtman, M.D., in which very small
doses of melatonin were found to induce sleep when given during the day,"
added Dr. Cooper.
Melatonin, a hormone secreted by the pineal gland, plays a key role in
regulating the body's sleeping/walking rhythm. Typically, melatonin
secretion begins in the late evening and peaks in the early morning.
Interneuron Pharmaceuticals, Inc., is engaged in the development and
commercialization of innovative pharmaceutical products for neurological and
behavioral disorders. Through three other subsidiaries, Intercardia, Inc.,
Progenitor, Inc. and Transcell Technologies, Inc., Interneuron is developing
products and technologies related to cardiovasular disease, gene therapy,
stem cell production, carbohydrate synthesis and drug transport.
CONTACT:
Interneuron Pharmaceuticals, Inc., Lexington
Glenn L. Cooper, M.D./William B. Boni, 617/861-8444
