http://exhibits.library.stonybrook.edu/mfp/files/original/57be672cc879ca951cc824deee078be0.pdf 48d41624257c295c5610460bcf7e4b0d PDF Text Text Wyn—w mun-r— October 26, 1970 Dr. Harold Heiselas York State Narcotic New Addiction Control Commission 1855 Broadway New York, New York 10023 Dear Harold, RE: Contract 044116 We are actively pursuing the development of a long acting narcotic antagonist for the prophylaxis and treatment of opiate dependence. Our clinical studies with naloxone will be reinstituted with new supplies about November 1; the contract with Food and Drug Research is operational; and we are negotiating another with Alza Corporation.> At 4 meeting we became acquainted with another fl 5050, developed by Beckett and Colman of Hull, the June antagonist, England, for veterinary use. This antagonist is another ”pure" antagonist, 16»20 times as potent as naloxone in animal trials, both abroad and at the University of Michigan in studies by Villareal. We have received the cooperation of Reckitt and Colman to undertake human studies. With a permit to import issued by the FBN, I now have 10 grams M 5050. Before clinical assays may be done, the FDA requires minimal animal toxicology data in 2 species, and such tests have not been done — they are not necessary in veterinary medicine. have submitted copies of the available data on M 5050 to the FDA, inquiring as to the minimal testing they would accept for an IND. On the basis of our discussion and my past experience, they will require testing in 2 species for 6 months with complete pathology. Such work is done by various university and commercial laboratories on a contract basis, and usually costs between $20,000 and $40,000, depending on the species studied. We We have written to Dr. Louis Harris of the University of Earth Carolina for his estimate of the FDA requirements and cooperation in this testing. He is the pharmacologiat who developed cyclazocine at Sterling—Winthrop and is the most capable authority in this complex field. �~2- Dr. Meiselas October 26, 1970 1970~71 contract with the Narcotic Addiction Control Commission, we requested additional will recall that in our You to purchase supplies of neloxone. Fortunately, Endo Laboratories were persuaded to make 6 Kg naloxone available sums at cost. no We are writing to: l) Acquaint the Commission with our progress and thoughts; Request your review of the enclosed data, and ask that an opportunity he provided us to meet with Commission representatives to discuss this program; and, 2) Enable us to request use of the naloxone supply funds for a subcontract for animal pharmacology of M 5050, to shorten the time from animal testing to clinical trial. 3) Thank you for your interest. Sincerely yours, Vax Fink, M.D. Professor of Psychiatry MF:kt encs: FDA Ltr. M Submission L. Harris 5050 reprints � 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: Meiselas, Harold Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-024-9-520 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