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 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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