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Novel, sustained-release naltrexone for opiate abuse

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
54333
Program Year/Program:
2001 / SBIR
Agency Tracking Number:
1R43DA013531-01A1
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ALKERMES, INC.
64 SIDNEY ST CAMBRIDGE, MA 02139
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2001
Title: Novel, sustained-release naltrexone for opiate abuse
Agency: HHS
Contract: N/A
Award Amount: $98,980.00
 

Abstract:

DESCRIPTION: While opiate agonists can be effective for treating abusers, they are. inappropriate in many circumstances. The opiate antagonist naltrexone (NTX) has been approved by the FDA and endorsed by NIDA and other government agencies as an important treatment alternative for heroin abuse. However, all authorities recognize that poor compliance greatly limits naltrexone's effectiveness. We propose to develop a novel, high-load, sustained release formulation of NTX that, by its nature, will improve compliance. As a 30-day, sustained release formulation, it should also enhance efficacy, patient acceptance and reduce side effects by eliminating the wide daily fluctuations in plasma levels and significant first pass metabolism associated with oral therapy. The specific aims of this proposal are to: (1) develop several novel formulations which can provide high sustained NTXplasma levels, while -avoiding the high bursts currently associated with high load formulations; (2) select a lead formulation based on initial in vivo pharmacokinetic testing; and (3) further evaluate the lead formulation for local irritability and pharmacokinetics. We will then proceed rapidly into clinical trials to demonstrate safety and efficacy of the formulation to achieve regulatory approval for treating opiate addicts. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

Principal Investigator:

Raymond T. Bartus

Business Contact:


6174940171
JAMES.FRATES@ALKERMES.COM
Small Business Information at Submission:

ALKERMES, INC.
64 SIDNEY ST CAMBRIDGE, MA 02139

EIN/Tax ID: 232472830
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No