http://exhibits.library.stonybrook.edu/mfp/files/original/5666f65a01324b7556aa0da8c8eee72a.pdf 465dc4b9c905d77ba07b2334e8698efb PDF Text Text .w ‘1‘ mn my." ,,,, ... .. October 7, 1970 Dr. Dorothy Dobbs Food and Drug Administration 18733 Walker's Choice Rd. Gaithersburg, Maryland 20760 Dear Dr. Dobbs: to writing to ask your advice as to the steps necessary M 5050 new narcotic antagonist, undertake human assays of a I am — diprenorphine. Since 1965, we have been interested in treating opiate a dependence with narcotic antagonists. This therapy is based onwhich and Martin Lexington, Wikler at theoretic model, developed by views opiate dependence as a psychological and physiological conditioning, requiring an active extinction of conditioned responses for successful. therapy. Following their lead, as therapeutic agents. we have assayed cyclazocine and naloxone short duration of action of both drugs has led us to seek ways of extending their action, including the development of silastic implants, in which duration is related to the rate of leaching into the tissues and the amount of drug in the implant. Since amount of drug and size of implant are directly related, we are seeking as potent an antagonist as we can find for this purpose. A June 4 we convened a conference to review the available by the clinical and pharmacological data, and were heartened developing for of suggestions clinical reports and by the variety a long acting formulation. On V discussant led us to M-SOSO, a narcotic compound produced by Reckitt and Colman of Hull, England. In animal assays, it is a potent has reported it to antagonist without agonistic properties. Villareal Colman and are preparing Reckitt naloxone. be 16-20 times as potent as narcotic M-99 with a potent - very to market this compound in a package medicine. to control large animals in veterinary One data, nor are they now interested in developing the compound for human use. They are willing, however, to make supplies available for our assay, both in animal pharmacology and clinical. They have no human �., . ‘w -- r “igummww . -, :9 mama- mum rum wane-m1 :‘ "V‘mmfwf‘wfimmwrmv'ww Dr. Dobbs - ;“ nmmlr’lv‘wfiww rummrwwww-w W‘r—wwizfi-Im»)" w |~ October 7, 1970 ~2- Our research program is supported by contracts from the New York State Narcotic Addiction Control Commission, and we believe they will support this project. I am writing to ask your advice and assistance in formulating the animal toxicology data prerequisite to our proposed clinical assays. We would first determine if M 5050 is an antagonist to heroin, at what dose, and for what duration after a single dose. If antagonism is demonstrated, we would then define the oral or parenteral dose necessary to produce continuous antagonism to heroin. (In this study we would parallel the assays we have made of cyclazocine and naloxone.) We Enclosed are copies of all the data on M 5050 available to us. also have an initial 10 granssupply for study. What additional data are necessary for us to file for single dose assays in man? we fol low? What toxicology data are needed? What procedures should In addition to the M 5050 data, I am enclosing a summary of the meeting as published in §gigngg; and reprints of our studies of cyclazocine, naloxone and heroin, that will provide the background for our interest in this program. June 4 If useful, I this request with Many would be pleased to visit your you and your associates. offices to discuss thanks for your help. Sincerely yours, Max Fink, M.D. Professor of Psychiatry MF:kt cc: A. M. Freedman, 24.0. H. M. Meiseles, Luger , NACC NACC wuov'n - are "rm—Iva. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence to: Dobbs, Dorothy Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-024-9-557 Date A point or period of time associated with an event in the lifecycle of the resource 1970 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York). Language A language of the resource en-US Format The file format, physical medium, or dimensions of the resource application/pdf Publisher An entity responsible for making the resource available Contributor An entity responsible for making contributions to the resource Correspondence