Reducing Methadone's Arrhythmic potential

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HL095160-01A1
Agency Tracking Number: HL095160
Amount: $102,910.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solitcitation Year: 2010
Solitcitation Topic Code: NHLBI
Solitcitation Number: PHS2010-2
Small Business Information
ACADEMIC PHARMACEUTICALS, INC.
21 N. SKOKIE HWY, SUITE G-3, LAKE BLUFF, IL, 60044
Duns: 874285984
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JOHN SOMBERG
 (312) 942-6590
 JSOMBERG.API@COMCAST.NET
Business Contact
 JOHN SOMBERG
Phone: (847) 735-1170
Email: jsomberg.api@comcast.net
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): Methadone is an important long-term maintenance therapy for drug addiction and currently is frequently used for analgesia. However, methadone prolongs the QT interval on the electrocardiogram and this increases risk for life threatening arrhythmias and has led to the FDA's placing a black box warning on methadone's label. Initial studies in our laboratory have shown that one of the stereoisomers of methadone causes significantly less QT prolongation and this isomer possesses the analgesic effect of methadone. The studies outlined in the grant propose to confirm the safety of the R isomer in a model to access proarrhythmia that the FDA proposes for the animal evaluation of arrhythmic risk and then to determine if the isomer causes less QT prolongation in the dog at therapeutic and higher than routine therapeutic doses of R methadone as compared to racemic methadone. These are necessary steps for the submission of a new drug application and the eventual commercial availability of the methadone isomer as a safer treatment for analgesia and addiction. PUBLIC HEALTH RELEVANCE: Methadone is frequently used for pain treatment and drug addiction, but the current formulation poses a serious risk of arrhythmias. The R isomer of methadone does not cause the same electrophysiologic changes (QT prolongation) and thus would not pose the same risk for arrhythmias. Studies in this grant set out to show that the R isomer is a safer methadone and would pose less of a risk for life threatening arrhythmias to patient.

* information listed above is at the time of submission.

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