http://exhibits.library.stonybrook.edu/mfp/files/original/3941ae7999e9c16737fc4c114942316a.pdf 0ac65a569c13535f11d3ffbfb9e4a0d1 PDF Text Text June 22, 1971 Dr. Lawrence Bergner Health Services Administration 185 Worth New Street York, New York 10013 Dear Dr. Bergner: In continuing our program of study of the role of narcotic antagonists in opiate dependence, we are interested in assessing the clinical use of a new narcotic antagonist, .-5050. In animal trials. it is 8-10x as potent (on a mg basis) as naloxone with a duration that is slightly longer. In contrast to the manufacturing problems of naloxone, we have been assured by the manufacturer that adequate supplies for clinical purposes can be made. We believe clinical trials with M~5050 should be undertaken. filed toxicity studies adequate to meet our standards prior to such trials. To file an IND we require animal toxicology data. There are not available from either the An IND must be and pro—clinical manufacturer or his U.S. representatives. have obtained proposals for the safety evaluation of M~5050 meet our needs, including single oral and intravenous studies in rats, intravenous studies in dogs, oral administration We sufficient to for 13 weeks to rats and to monkeys, from various laboratories. principal proposals are from the Food and Drug Research Laboratories of Maspeth, L.I. , and Woodard Research Corporation of Herndon, Virginia. two The To carry out these studies. prepare and file an IND, prepare the necessary protocols, and undertake the initial human trials using the heroin ”challenge” model will require funds for: (1) (2) (3) Animal toxicology $31,500 7,500 Nursing and psychiatric 4,500 Consulting costs support $ 43,500 This study will require 18-24 weeks for the animal toxicology; for the IND; and 10—12 weeks for the initial 6 weeks heroin challenge data. �Dr. Bergner June 22, 1971 —2- We trust these data will be sufficient to provide the basis for definitive clinical trials in opiate dependent for trials in developing a long-acting formulation. subjects, and Sincerely yours, Max Fink, M.D. Professor of Psychiatry � 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: Bergner, Lawrence Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-025-5-299 Date A point or period of time associated with an event in the lifecycle of the resource 1971 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