Veterans Affairs

Drug therapy to induce bowel movements in individuals with spinal cord injuries or neurological disease

Transdermal delivery of neostigmine and glycopyrrolate driven by iontophoresis shows effectiveness in human trials

Medical & Biotechnology

Scientists at the VA have recently developed therapeutic and delivery method for the treatment of bowel movement difficulty in patients with spinal cord injuries or neural disorders. The patented technology is available via patent license agreement to companies that would make, use, or sell it commercially.

Having regular bowel movements with complete evacuation is difficult for people with spinal cord injuries and those with neural disorders such as dementia, multiple sclerosis, or amyotrophic lateral sclerosis. To address this condition, VA researchers have previously proposed a drug combination consisting of an acetylcholinesterase inhibitor, such as neostigmine, and an anticholinergic agent, such as glycopyrrolate to treat this condition. Tested in human subjects this combination could be safely administered in repeated doses over a period of time in an ongoing bowel care program for subjects with chronic intestinal pseudo-obstruction. However, administration of the drug combination proved to be difficult due to ineffectiveness or ease of use. IV administration and intramuscular administration of the drug combination were both highly effective but impractical for ongoing at-home bowel care as they require a trained health professional. Subcutaneous administration suffered from slow adsorption and consequently failed to induce bowel evacuation. Oral or sublingual administration similarly suffered from a slower and less reliable rate of absorption. Intranasal administration failed to induce bowel evacuation.

In response to these delivery issues and to provide a method for treatment by a patient at home, the researchers have identified and tested the use of iontophoresis for delivery on a regular basis in a home setting without the need of a trained health professional. Iontophoresis (electromotive drug delivery) is a transdermal method utilizing an electric voltage gradient on the skin to move therapeutics from a patch to the derma. Initial patient studies have shown that transdermal administration of neostigmine/glycopyrrolate by iontophoresis appears to be a practical, safe, and effective approach to induce bowel evacuation in individuals with spinal cord injury.

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