Reducing Methadone's Arrhythmic potential

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$102,910.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL095160-01A1
Award Id:
96296
Agency Tracking Number:
HL095160
Solicitation Year:
n/a
Solicitation Topic Code:
NHLBI
Solicitation Number:
n/a
Small Business Information
21 N. SKOKIE HWY, SUITE G-3, LAKE BLUFF, IL, 60044
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
874285984
Principal Investigator:
JOHNSOMBERG
(312) 942-6590
JSOMBERG.API@COMCAST.NET
Business Contact:
JOHNSOMBERG
() -
jsomberg.api@comcast.net
Research Institute:
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 pos sesses 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 iso mer 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 availabi lity 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 th reatening arrhythmias to patient.

* information listed above is at the time of submission.

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