A NEW METHOD FOR TREATING SLEEP DISORDERS

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.