Inhaled dopamine agonist for late stage Parkinsonism

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$281,289.00
Award Year:
2003
Program:
SBIR
Phase:
Phase I
Contract:
1R43NS045505-01
Award Id:
66721
Agency Tracking Number:
NS045505
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
ALEXZA MOLECULAR DELIVERY CORPORATION, 1001 E MEADOW CIR, PALO ALTO, CA, 94303
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
JOSHUA RABINOWITZ
(650) 687-3903
JRABINOWITZ@ALEXZA.COM
Business Contact:
JOSHUA RABINOWITZ
(650) 687-3902
JRABINOWITZ@ALEXZA.COM
Research Institute:
n/a
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.

* information listed above is at the time of submission.

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