Obesity101.com THE LATEST IN OBESITY RESEARCH AND WEIGHTLOSS DRUG DEVELOPMENT Join our list More information Bringing a new drug to market. Introduction. The information below will give readers an idea of the type of compounds that are being investigated for future use in the treatment of obesity. Many of the compounds and genes described here will never produce a viable obesity medication. In some cases, a drug has not yet been synthesized, and the pharmaceutical company is looking at ways to use a protein or enzyme to create a medication. In preclinical research is it common for drugs to be developed and then abandoned if they do not produce promising results. STEPS IN THE US NEW DRUG APPLICATION PROCESS PRECLINICAL RESEARCH Synthesis and purification Animal testing Institutional review boards INVESTIGATIONAL NEW DRUG APPLICATION CLINICAL STUDIES Phase I Phase II Phase III NEW DRUG APPLICATION POST APPROVAL RESEARCH See the FDA CDER site for a clickable image map describing the different stages of the drug approval process in detail. The investigation of new drugs is fraught with uncertainty. A drug candidate can be shown to be ineffective or dangerous at any stage of development. A pharmaceutical company may decide not to continue research on a drug for much more mundane reasons as well, like delivery method. An injectable drug will be used by many fewer patients than an oral formulation, and if that drug is not likely to be used by classes of patients who take injections anyway, like insulin dependent diabetics, a drug may be abandoned for those reasons alone. It can take 10 or 12 years from the time a new drug is discovered until it goes to market, and it costs the average company $359 million to bring a new medication from the laboratory to the pharmacist's shelf, according to a 1993 report by the Congressional Office of Technology Assessment. Recouping research and development costs is a major factor in pricing new drugs, and a reason why pharmaceutical companies are given a 17 year patent on any new drug brought to market. Preclinical studies. In the preclinical phase a new drug is synthesized, and the pharmacological activity and therapeutic potential are tested in animal studies and on tissue samples, enzymes, cloned receptor sites and computer models. In this stage, researchers evaluate compounds for pharmacological activity, therapeutic promise, and potentially harmful biological properties. Only one in 5,000 compounds that enter preclinical research will ever be tested on humans. Investigational new drug application (IND). Before a pharmaceutical company can begin human testing of a drug, it must file an investigational new drug application (IND) with the Food and Drug Administration (FDA). The application contains a compilation of all known information on the compound, a description of the clinical research plan, and the specific protocol for phase I study. Unless the FDA says no, the IND is automatically approved after 30 days and clinical tests may begin. Clinical trials. Three phases of human trials are conducted before a new drug application (NDA) is made to the FDA, and each phase has a specific purpose. Only one in 5 drugs tested on humans ever comes to market. Phase I. Safety studies are conducted on small numbers of healthy volunteers, generally 10 to 30, to confirm that the drug is sufficiently safe to proceed with testing on larger numbers of patients. Phase I studies do not assess effectiveness Phase II. Efficacy studies are conducted on larger numbers of subjects, 100 to 200 patients. In this phase, the drug is tested on volunteers who have the disease or condition for which the drug is being developed. Phase II trials are conducted to determine the drug's potential usefulness, short term risks and proper dosage. Phase III. In the clinical testing phase the drug is tested on a large number of patients. This phase can involve thousands of subjects at multiple treatment centers. The purpose of Phase III trials is to verify Phase II results, prove the drug is active in large numbers of patients, and demonstrate that it is more effective than currently approved treatments. New drug application If a drug makes it though the three stages of clinical trials, the testing pharmaceutical company submits a new drug application (NDA) to the FDA. An NDA contains thousands of pages of information, which are reviewed by the FDA Center for Drug Evaluation and Research. Generally the NDA is also reviewed by an advisory committee, which may recommend or reject the drug candidate. However, the FDA may override the advisory committee's recommendation. Obesity medications are reviewed by the FDA endocrinologic and metabolic drugs advisory committee. Post approval research Clinical trials, called Phase IV studies, may be conducted on drugs after they are approved. Sometimes the FDA requires post-market testing as a condition of approval, but companies often conduct post-market studies in the absence of regulatory mandate. For more information on the FDA approval process, see the Center for Drug Evaluation and Research's Drug Development Handbook Home|Subscribe|Archives|Drug info|Contact|Media & Links|Site index|FAQs|Doctors/meetings|Admin Obesity-news is a publication of Hirsch Communications. An on-line subscription is $104.00 per year, payable in advance by check, money order, American Express, Discover, VISA or Mastercard. Subscribing is simple using our secure on-line subscription form. Obesity-news also accepts fax orders at 703/960-7462 and mail orders at PO Box 19316, Alexandria, VA 22320-0316. Copyright 1997-2008, all rights reserved. IMPORTANT: All information in this publication is believed to be accurate and true. Publisher is not liable for omissions or inaccuracies. Information in this newsletter is for educational purposes only and should not be construed as medical advice, or be used in lieu of consultation with a health care provider.