A 30-DAY INJECTION FOR TREATMENT OF URINARY INCONTINENCE
A 30-DAY INJECTION FOR TREATMENT OF URINARY INCONTINENCE
批准号:
6298897
负责人:
ELIE NUWAYSER
金额:
$10.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2001
资助国家:
美国
项目状态:
已结题
起止时间:
2001-04-01 至 2002-09-30
中文摘要
描述(逐字摘自申请人摘要):非自愿损失
英文摘要
DESCRIPTION (Verbatim from the Applicant's Abstract): The involuntary loss of
urine while awake or asleep is a malodorous social stigma, commonly concealed
by its embarrassed victim with a mountain of absorbent pads. An estimated l 0
million Americans are incontinent, at a cost of $10 billion/year. As much as 25
percent of nursing time in geriatric hospitals is consumed dealing with
incontinence.
The most common conditions are urge incontinence, stress incontinence, and
neurogenic bladder disorders. Oxybutynin is commonly used for the treatment of
urge incontinence and neurogenic bladder disorder, but not for stress
incontinence. Conventional oxybutynin therapy involves a dose of 5 mg taken 3
times daily in the form of tablets. However, since its oral bioavailability is
only 6-9 percent, an injection capable of delivering 1-2 mg/day for 30 days
would cover the therapeutic range. The goal of this program is to develop a
biodegradable injectable microsphere system for sustained release of
oxybutynin. The microspheres will be targeted to deliver the drug for a period
of one month.
In preliminary studies, BIOTEK prepared several depot injectable formulations
of oxybutynin microspheres using FDA approved biodegradable
polylactide-co-glycolide polymer. The 6-month Phase I SBIR work will confirm
the reproducibility and optimize the method of preparation of a depot
formulation. It will characterize the properties of the microspheres and
determine the rate of release of the drug m vitro and in rabbits. If
successful, Phase II will focus on clinical evaluation of the formulation in
volunteers at the West Roxbury VA Hospital in Massachusetts.
PROPOSED COMMERCIAL APPLICATION:
An injectable depot form of oxybutynin would find use in several conditions where chronic
administration of the drug is known to be effective. The number of U.S. subjects who suffer
from these conditions is high and the associated health cost is more than $10 billion/year.
While oxybutynin is not the only mode of therapy, the choice is influenced by the low oral
bioavailability and hence, the low dose of the drug. From a commercial standpoint, even a
small penetration of this market would by itself represent an impressive business opportunity
and ample return on investment.
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