# Presentation: 128073

## For Drug Discovery and 

**For Drug Discovery and **
**   ****Development at NIDA**

## 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.”

## The Division of Treatment Research & Development

**is looking for treatments that**
- 	•  **Block effects **
**	****•  ****Reduce craving **
**	****•  ****Moderate or eliminate withdrawal symptoms**
**	****•  ****Block or reverse the toxic effects of abused ****	****   drugs**
**	****•  ****Prevent relapse**
**of drugs of abuse (cocaine, methamphetamine, opiates)**

## 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.**

## 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**

## Market Analysis Model

_**Factors determining profitability**_
**Development cost**
**Sales of the product**
**Cost of Manufacturing, distributing and marketing the product**
**Duration of the development and product/sales life**

## Critical Market Barrier Perceptions

**Small and uncertain market for cocaine addiction**
** ****pharmacotherapy.**
**Substance abuse treatment system that limits access**
** ****to the market.**
**Limited and uncertain payment for pharmacotherapy.**
**Industry perception of science base readiness.**

## Government Interventions:Increasing Profitability

**Funding of basic science and clinical trials**
**NDA Phase**
**	****Fast Track approval**
**	****Orphan Drug status (ODS)**
**	****Market exclusivity other than ODS**
**	****Less stringent Phase IV clinical trial requirements**
**	****Marketing**

## 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

## 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)**

## Preclinical Resources

**Opiate Treatment Discovery Program**
**Cocaine Treatment Discovery Program**
**Safety Assessment Program**

## 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)**

## 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

## 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

## Slide 16

## Clinical  Support(CRADA required)

**Phase I (safety)**
**Phase II (dose-finding, proof of concept)**
**Phase III (multi-site)**
**Phase IV (Clinical Trials Network)**

## Chemistry Support

**Non-GMP and GMP synthesis**
**Formulation**
**Stability studies**
**PK studies**

## 	     DOES NOT WANT 

- Uncle Sam

**	****     ****DOES NOT WANT**** **
**YOUR INTELLECTUAL PROPERTY RIGHTS!**

## Who To Call?

**Cocaine Treatment Discovery Program –  Jane Acri, Ph.D. (**_[jacri@nih.gov](mailto:jacri@nih.gov)__)  301-443-6270_
**Opiate Treatment Discovery Program – David McCann, Ph.D.  (**_[dmccann@nih.gov](mailto:dmccann@nih.gov)__) 301-443-6270_
**New chemical entities/Treatment related grant concepts – Jamie Biswas, Ph.D. (**_[jb168r@nih.gov](mailto:jb168r@nih.gov)__)  301-443-5280_

## www.nida.nih.gov