Opiate antagonist therapy is an important treatment for recently withdrawn opiate addicts. Buprenorphine is a mixed agonist-antagonist which eliminates physiological reinforcement by blocking subjective opiate reward. Recently marketed as sublingual tablets, buprenorphine is very effective and is preferred by subjects to methadone or naltrexone. BIOTEK proposes to improve buprenorphine therapy by developing a 3-day transdermal delivery system. Such a patch would provide steady maintenance of agonist therapy to foster compliance. If such a patch can be made to contain relatively little buprenorphine, the motivation for subversion and abuse will be minimal. In vitro results on human skin obtained during Phase I strongly support the feasibility of such a patch, and rabbit irritation studies suggest that it will be non-irritating. Phase II will establish patch specifications suitable for GMP manufacture, confirm the in vitro performance of the selected formulation, prepare and characterize GMP clinical samples, initiate stability studies, submit an IND, and conduct an initial human study of safety and pharmacokinetics.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DA015573-02
Application #
6783639
Study Section
Special Emphasis Panel (ZRG1-SSS-S (11))
Program Officer
Thomas, David A
Project Start
2002-08-01
Project End
2006-06-30
Budget Start
2004-07-05
Budget End
2005-06-30
Support Year
2
Fiscal Year
2004
Total Cost
$321,424
Indirect Cost
Name
Biotek, Inc.
Department
Type
DUNS #
021011499
City
Woburn
State
MA
Country
United States
Zip Code
01801
Lanier, Ryan K; Umbricht, Annie; Harrison, Joseph A et al. (2008) Opioid detoxification via single 7-day application of a buprenorphine transdermal patch: an open-label evaluation. Psychopharmacology (Berl) 198:149-58
Lanier, Ryan K; Umbricht, Annie; Harrison, Joseph A et al. (2007) Evaluation of a transdermal buprenorphine formulation in opioid detoxification. Addiction 102:1648-56