 |
Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.
VA TECHNOLOGY OPPORTUNITY BRIEF
Neostigmine-Glycopyrrolate for Bowel Care in Individuals with Spinal Cord Damage and Advanced Neurological Disease
(02-095)
OPPORTUNITY:
The Department of Veterans Affairs (VA) is seeking a commercial partner to
further develop this technology through a Cooperative R&D Agreement (CRADA)
to expedite bringing it to market. This technology is a therapeutic drug
compound to regulate bowel movements in individuals with spinal cord injury
(SCI) and advanced neurological diseases.
BACKGROUND:
Patients with spinal cord injuries and advanced neurological disorders suffer
from a condition called neurogenic bowel dysfunction, which is mainly associated
with difficulty with evacuation of bowels. Difficulty in evacuation arises
as a result of neurogenic bowel dysfunction and is common in patients not
only with spinal cord injuries but also with amyotrophic lateral sclerosis,
Parkinson's disease, spina bifida and multiple sclerosis. This condition
will affect the quality of life of the individuals and may lead to systemic
and local complications. The systemic complications include transient ischemic
attacks, syncope, arrhythmias, and myocardial infarction. Local complications
include stercoral ulcer, proctitis, anal prolapse, hemorrhoids, infection,
ischemia (gangrene of the bowel), intestinal obstruction, perforation, incontinence,
and volvulus.
The traditional methods to manage the problem of difficulty with evacuation
are laxatives, enemas (saline and oil), PEG (polyethylene glycol) lavage, and
lactulose or these methods combined with digital stimulation. These methods
are time consuming and have unsatisfactory results.
TECHNOLOGY OVERVIEW:
Medications are administered using various methods, each of which has advantages
and limitations. The leading drug delivery techniques include oral ingestion;
intravenous, subcutaneous and intramuscular injection; inhalation; and transdermal
and transmucosal administration. For the drug to be effective it must reach
an intended site in the body, at an effective concentration, and for an appropriate
length of time. Therefore, drug delivery technology is often a critical component
in the formulation of pharmaceutical products and is used to deliver drugs
to desired sites within the body in a safe and efficacious manner.
The technology is a combination of two drugs: neostigmine, used as a reversible
anti-cholinesterase inhibitor, and glycopyrrolate, an anti-cholinergic and
anti-spasmodic. Both drugs are available generically in injectable form. Neostigmine
is known for its side effects on the gastrointestinal tract, including an increase
in motility of the colon resulting in defecation, and on the cardiovascular
system, leading to a slowing of the heart rate. The inventor has taken the
advantage of the side effect of neostigmine on the gastrointestinal tract and
has used the drug to correct the difficulty with evacuation in SCI patients.
To control the unwanted side effects of neostigmine on the cardiovascular system
without blocking the desired effects on gastrointestinal tract, the glycopyrrolate
compound was added in an appropriate dose.
Thus the technology permits the safe and rapid evacuation of the bowels without
using traditional laxatives, enemas, or digital stimulation.
TECHNICAL MERIT:
The advantages of this applied technology over established methods are that
it: avoids incomplete evacuation of the bowels leading to incontinence; avoids
physical trauma; reduces the risk of ano-rectal problems, such as bleeding
hemorrhoids and anal fissures; and reduces the loss of dignity of the patient.
The current form of administration is intravenous (IV) and intramuscular (IM)
injection of the drug compound, which requires professional supervision thus
limiting usage mostly to healthcare settings (hospitals and nursing homes).
The goal is to deliver this drug combination with ease of administration so
that patients can employ it in the home setting without the attendance of a
healthcare professional.
Patients who have used this technology report complete bowel evacuation within
ten minutes of being administered the therapeutic compound without side effects.
The VA has conducted 53 studies on 17 individuals over a one-year period with
satisfactory results.
PATENT STATUS:
A provisional patent application was filed on Sept. 26, 2002 (60/413,456)
A US patent application was filed on Sept. 25, 2003 (10/672,241).
Federal register: March 30, 2004 (Vol. 69, Number 61) p. 16634
FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov