Novel neutral antagonist for the treatment of opioid-induced adverse effects

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$182,966.00
Award Year:
2007
Program:
SBIR
Phase:
Phase I
Contract:
1R43DA023725-01
Award Id:
85515
Agency Tracking Number:
DA023725
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
AIKO BIOTECHNOLOGY, INC., 2 Union Street, PORTLAND, ME, 04101
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
785177044
Principal Investigator:
JANET YANCEYWRONA
(207) 329-6093
JWRONA@SUSCOM-MAINE.NET
Business Contact:
() -
jyancey@aikobiotech.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): AIKO Biotechnology, Inc. is a start-up biotechnology company focused on developing safe and effective therapeutics for the management of pain and addiction. Opioid drugs are the standard of care in the treatment of pain . However, opioids produce a spectrum of adverse effects, including opioid-induced bowel dysfunction, that limit their clinical utility. Opioid antagonists have shown efficacy in reducing unwanted side-effects, but the antagonists themselves cause serious side effects (e.g., excessive abdominal cramping). Based on a new understanding of opioid receptor pharmacology, AIKO scientists have developed and patented the use of 'neutral' opioid antagonists that block the unwanted actions of opioid drugs, but have s ignificantly lower side effects than currently used opioid antagonists. Results from this project will establish the feasibility of developing a lead drug candidate that is a peripherally-selective, long-acting neutral antagonist expected to block the unwa nted peripherally mediated opioid side effects while preserving analgesic actions. Specific aims include: (i) determining the relative selectivity of the neutral antagonist for peripheral vs. central opioid receptors to define a therapeutic dosage range th at relieves peripheral side effects without inhibiting analgesia; (ii) comparing the opioid withdrawal precipitated by the neutral antagonist to other antagonists under development showing that the AIKO neutral antagonist evokes limited adverse side effect s; and (iii) determining the maximum tolerated doses (acute and sub-chronic) of the AIKO neutral antagonist as an early indication of its safety and tolerability for humans. Research will be conducted using established rodent models and procedures for eval uation of opioid pharmacology. These data are critical for discussions with the Food and Drug Administration that will lead to successful clinical trial design and an Investigational New Drug Application. This research addresses a significant problem with opioid analgesics, which solution will provide better management of addiction, treatment of acute and chronic pain, and relief from opioid-induced bowel dysfunction. Successful development of a neutral opioid antagonist will lead to safer, more efficacious pain and addiction management that is needed by millions of people each year. Opioid analgesics remain the standard of care for moderate to severe, acute and chronic pain, and are prescribed for millions of people each year. The use of opioids leads to ad verse effects including opioid-induced bowel dysfunction (e.g., severe constipation, nausea and vomiting) and post-operative ileus. AIKO Biotechnology will determine the feasibility of using its proprietary peripherally restricted opioid neutral antagonist for treatment of adverse opioid effects, thereby decreasing morbidity and mortality associated with pain management.

* information listed above is at the time of submission.

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