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A NEW METHOD FOR TREATING SLEEP DISORDERS

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44NS043129-02
Agency Tracking Number: NS043129
Amount: $494,477.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
BIOTEK, INC. 21-C OLYMPIA AVE
WOBURN, MA 01801
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 L NICHOLS
 (781) 938-0938
 BIO21TEK@AOL.COM
Business Contact
 E NUWAYSER
Phone: (781) 938-0938
Email: BIO21TEK@AOL.COM
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): BIOTEK has developed a transdermal
melatonin formulation capable of producing flux levels high enough to allow a
small patch to deliver a night-time melatonin pulse similar to that of healthy
young adults. Such delivery should foster drowsiness, restful sleep, and alert
waking more effectively than available oral dose forms and would also be more
easily administered to impaired or uncooperative subjects. Because transdermal
melatonin provides non-invasive delivery of a human hormone at natural levels,
it should not lead to tolerance or harmful side effects. Transdermal melatonin
may be of value to night shift workers, elderly individuals who lack an
endogenous high-amplitude melatonin cycle, long distance air travelers, and
those with sleep or seasonal affect disorders. In Phase I GMP patches were made
and characterized, stability studies were initiated, a human Clinical Protocol
was developed with the Brigham and Women?s Sleep Center in Boston, MA, and a
draft IND was prepared. Phase II will conduct a human clinical study aimed at
establishing safety and testing efficacy under well-controlled conditions.

PROPOSED COMMERCIAL APPLICATION: A melatonin patch should encourage development of transdermal systems for other cyclic hormones, leading to products capable of modifying or restoring other types of hormone-mediated behavior.

* Information listed above is at the time of submission. *

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