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Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DA015240-01
Agency Tracking Number: DA015240
Amount: $99,965.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
WOBURN, MA 01801
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (781) 938-0938
Business Contact
Phone: (781) 938-0938
Research Institution

DESCRIPTION (provided by applicant): The overall objective of the program is to
develop a new more economical sustained action injectable formulation of
-buprenorphine, based on microcapsules prepared by BIOTEK's air suspension
process. The microcapsules will be used in a large placebo controlled study in
Phase II of the SBIR program. Recently we tested 30-day buprenorphine
microcapsules in five (5) heroin addicts at the Johns Hopkins University School
of Medicine, Behavioral Pharmacology Research Unit.

For all five subjects the depot buprenorphine medication appeared to provide
remarkable relief from opioid withdrawal without evidence of intoxication or
respiratory depression over the six weeks of post-depot observation and
assessment. Furthermore, the formulation was very effective in dramatically
reducing responsiveness to exogenous opioid challenge for a duration of at
least several weeks. Clinically, all five participants successfully achieved
opioid detoxification, without other medications for withdrawal relief, and
without clinically significant withdrawal signs or symptoms. During the
subsequent 2-week outpatient phase all patients reported abstinence from
opioids and urine toxicology samples were negative for opioids. These
remarkable and very exciting findings compel us to drive forward and expand and
accelerate the testing of depot buprenorphine in a large population of heroin
addicts with appropriate placebo controls.

Support is sought under the SBIR program to develop and optimize a more
economic formulation of depot buprenorphine microcapsules, by using a new
process which produces a much higher yield (5-6 fold increase) of microcapsules
in the injectable size range. In preliminary studies detailed in this
application, we have demonstrated significant reduction in manufacturing costs
and the equivalency of the buprenorphine release profile from the old and new

During Phase II of the SBIR program, microcapsule development will be
completed, a large number of vials will be prepared under cGMP. The current IND
will be updated and submitted to the FDA with a clinical protocol to test the
formulation in a larger population of heroin addicts with appropriate placebo
A sustained action opioid agonist/antagonist formulation, such as microencapsulated buprenorphine would be a significant advance. Once a month treatment is an economic advantage and allows staff members to devote more time to patients and less to dose administration. This formulation will provide opioid antagonism like that of naltrexone, but there would be less motivation for the post addict to drop out of therapy due to the agonistic action similar to that of methadone or LAAM. The overall treatment plan would not need to revolve about a rigid dosing schedule. Rather treatment could be designed to best benefit the patient, and an example of habitual drug taking behavior is eliminated. The drug thus becomes an adjunct not the major aspect of therapy.

* Information listed above is at the time of submission. *

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