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The NIDA Mission. NIDA's mission is to lead the nation in bringing the power of science to bear on drug abuse and addiction. This charge has two critical components: the first is the strategic support and conduct of research across a broad range of disciplines. The second is to ensure the rapid

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    2. The NIDA Mission “NIDA’s mission is to lead the nation in bringing the power of science to bear on drug abuse and addiction. This charge has two critical components: the first is the strategic support and conduct of research across a broad range of disciplines. The second is to ensure the rapid and effective dissemination and use of the results of that research to significantly improve drug abuse and addiction prevention, treatment, and policy.”

    3. The Division of Treatment Research & Development

    4. Estimates of Market Size Current Market for Cocaine Treatment 2 million people are addicted or heavy users. 800,000 – 900,000 may enter treatment at least once in a given year. On any given day: 250,000 are enrolled in treatment and 11,500 centers provide treatment. 40% are enrolled in primary treatment and 60% are enrolled in secondary treatment. $2 billion total spending per year: $23 per patient per day enrolled (including inpatient and outpatient), $9 per day for non-intensive outpatients.

    5. Estimates of Price, Market Size & Revenues A medication used by 250,000 patients, sold at $3.30 per day, will generate $300 million in Peak Annual Revenue (PAR) A medication used by 125,000 patients, sold at $6.60 per day, will generate $300 million PAR A medication used by 500,000 patients, sold for $2.50 per day, will generate $440 million PAR A medication used by 1 million patients, sold at $0.50 per day, will generate $200 million PAR

    6. Market Analysis Model

    7. Critical Market Barrier Perceptions

    8. Government Interventions: Increasing Profitability

    10. How Can NIDA Support Drug Discovery/Development for Small Businesses? Grants - SBIR/STTR Program Development programs - Screening programs - Drug substance and drug product manufacturing - Preclinical testing - Clinical trials

    11. Areas of Programmatic Interest Division of Treatment Research & Development Medicinal chemistry (novel compounds for the treatment of stimulant and opiate abuse) Pharmacology (development of preclinical pharmacological models of initiation, craving, drug-seeking behavior, dependence, withdrawal, relapse) Pharmacokinetics (PK/PD modeling of abused drugs and drug abuse treatments, PK and ADME studies, in vitro models for prediction of bioavailability of new treatment agents) Pharmaceutics (formulation studies to develop drug products with improved stability/bioavailability, new dosage forms) Clinical studies (controlled studies to assess drug abuse treatment medications, controlled trials for the development of new treatment agents)

    12. Preclinical Resources Opiate Treatment Discovery Program Cocaine Treatment Discovery Program Safety Assessment Program

    13. Cocaine Treatment Discovery Program Receptor and transporter binding assays Locomotor activity assays (mouse) Drug discrimination assays (rat and monkey) Self-administration assays (rat and monkey)

    14. Opiate Treatment Discovery Program Opiate receptor binding assays (specifically looking for selective kappa antagonists) Models of relapse to heroin self-administration (rats) NMDA antagonists Glycine partial agonists GABA-B agonist Cholinergic ligands Alpha-2 agonists Enzyme modulators

    15. Safety Assessment and Toxicology Program AMES assay for mutagenicity Acute and repeat dose studies (2 species) Drug interaction studies (cocaine, ethanol, morphine) Cardiovascular (conscious dog) Neurotoxicity Metabolism

    17. Clinical Support (CRADA required)

    18. Chemistry Support Non-GMP and GMP synthesis Formulation Stability studies PK studies

    20. Who To Call?

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