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Inhaled dopamine agonist for late stage Parkinsonism

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
66721
Program Year/Program:
2003 / SBIR
Agency Tracking Number:
NS045505
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Alexza Molecular Delivery Corporation
Alexza Molecular Delivery Corporation 1001 E Meadow Cir Palo Alto, CA 94303
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2003
Title: Inhaled dopamine agonist for late stage Parkinsonism
Agency: HHS
Contract: 1R43NS045505-01
Award Amount: $281,289.00
 

Abstract:

DESCRIPTION (provided by applicant): Later stages of Parkinson's disease are often characterized by motor fluctuations that include unpredictable and severely disabling periods of complete immobility ("off" periods). The most effective pharmacological treatments for "off' periods are dopamine agonists, with the dopamine agonist apomorphine especially effective. Apomorphine, however, suffers from low oral bioavailability and a low therapeutic index, which limit its clinical use. The aim of this proposal is to develop inhalation devices that deliver apomorphine and at least one other dopamine agonist drug rapidly into the blood stream, enabling patients to titrate their drug intake to the minimum effective dose, thus reducing side effects. Our company has developed a unique aerosol generation method that produces very small particles for efficient deep lung inhalation without any excipients or entrainers. This technique has already been proven to result in rapid systemic delivery of several FDA-approved drugs to mammals. In this Phase I grant, we will verify our ability to use this technology to deliver reliably and reproducibly a therapeutic amount of apomorphine as well as at least one other dopamine agonist compound. In a subsequent Phase II grant, we intend to build a delivery device with an optimized patient interface and complete animal pharmacokinetic and toxicology studies sufficient to initiate human clinical trials. Eventual clinical approval of a dopamine agonist inhalation device will allow patients with late stage Parkinson's disease to control their Disease more effectively, and thus increases their overall quality of life.

Principal Investigator:

Joshua D. Rabinowitz
6506873903
JRABINOWITZ@ALEXZA.COM

Business Contact:

Joshua Rabinowitz
6506873902
JRABINOWITZ@ALEXZA.COM
Small Business Information at Submission:

ALEXZA MOLECULAR DELIVERY CORPORATION
ALEXZA MOLECULAR DELIVERY CORPORATION 1001 E MEADOW CIR PALO ALTO, CA 94303

EIN/Tax ID: 770567768
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No