USA flag logo/image

An Official Website of the United States Government

Multi-day Pain Management Therapy with Novel Injectable Formulation

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R43DA032294
Solicitation Year:
2011
Solicitation Topic Code:
NIDA
Solicitation Number:
PA10-050
Small Business Information
ORBIS BIOSCIENCES, INC.
2002 W 39th Ave KANSAS CITY, KS 66013-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2011
Title: Multi-day Pain Management Therapy with Novel Injectable Formulation
Agency: HHS
Contract: 1R43DA032294-01
Award Amount: $253,678.00
 

Abstract:

DESCRIPTION (provided by applicant): Our long term goal is to widespread the use of PPF technology for promoting effective production of drug-encapsulating microparticles with uniform size and physical characteristics that can be leveraged to release a specific drug at controlled rates over multi-day periods in vivo after a single administration. For this proposal, we are specifically targeting a cost and dose-effective management of chronic pain with precisely tailored drug release characteristics. Chronicpain afflicts a large population in United States. Extended release formulations of safer (unscheduled) opioids can improve patient compliance and drug efficacy, and can limit the possibility of breakthrough pain, all without putting the patients at the risk of addiction. However, existing extended release opioid formulations are insufficient, and are limited to providing relief up to a maximum of 24 h. Using tramadol, an unscheduled opioid, this project aims to create a long-acting (up to 5-day) tramadolformulation in an injectable form to enhance pain relief and fill a critical innovation gap in the pharmaceutical market. The specific objective of this application is to optimize tramadol-loaded microspheres produced by PPF technology with a 5 day zero-order drug release profiles, imitating a constant infusion pump-like dosing (Specific Aim 1), and validate the results achieved with extended release formulations of tramadol in vivo (Specific Aim 2). Our overall hypothesis is that extended pain management therapy developed using uniform microspheres produced by PPF technology will offer a cost and dose-effective management of chronic pain with precisely tailored drug release characteristics, which will provide a more controlled and predictable drug release compared to tramadol-loaded microspheres fabricated using conventional methods, and significantly improve controlled release characteristics compared to contemporary commercially-available sustained-release pain management products (e.g., ULTRAM(R)). Multi-day chronic pain management therapy holds the potential to provide a revolutionary alternative for pain management. PUBLIC HEALTH RELEVANCE: Chronic pain afflicts a large population in United States. Extended release formulations of safer (unscheduled) opioids can improve patient compliance and drug efficacy, and can limit the possibility of breakthrough pain, all without putting the patients at the risk of addiction. However, existing extended release opioid formulations are insufficient, and are limited to providing relief up to a maximum of 24 h. Using tramadol, an unscheduled opioid, this project aims to create a long- acting (up to 5-day) tramadol formulation in an injectable form to enhance pain relief and fill a critical innovation gap in the pharmaceutical market.

Principal Investigator:

Maria Flynn
816-223-2662
maria@orbisbio.com

Business Contact:

Maria S. Flynn
816-223-2662
maria@orbisbio.com
Small Business Information at Submission:

ORBIS BIOSCIENCES, INC.
3901 RAINBOW BLVD. KANSAS CITY, MO -

EIN/Tax ID: 126236030
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No