TSRL has received a second-year Notice of Award from the National Institutes of Health to continue development of a microneedle patch for overactive bladder therapy.
The award provides nearly $1.1 million in continued support under Grant Number 5R44DK143799-03 for the project, titled Microneedle delivery of Trospium Chloride optimized for improved tolerance and patient outcomes in overactive bladder disease.
The project is led by principal investigator Dr Elke Lipka, president and CEO of TSRL.
Microneedle delivery for Trospium Chloride
TSRL is developing a self-administered microneedle patch designed to deliver Trospium Chloride, an established treatment for overactive bladder, at a steady therapeutic rate.
Trospium is an antimuscarinic medicine used to treat overactive bladder symptoms, including frequent urination and urgency. According to MedlinePlus, it works by relaxing bladder muscles.
The compound is also known for limited ability to cross the blood-brain barrier, a characteristic that has made it a relevant option for patients and clinicians considering cognitive side-effect concerns associated with some anticholinergic therapies.
“This continued NIH support is especially meaningful at a time when many research funding awards have faced uncertainty,” said Dr Lipka.
“For our team, it is also continued validation of the scientific rationale behind our microneedle delivery platform and its potential to address real patient challenges in overactive bladder.”
Patient-friendly delivery format
Overactive bladder affects millions of people in the United States and is particularly common among older adults. While anticholinergic therapies remain a standard treatment option, adherence can be affected by tolerability issues, inconsistent oral bioavailability and peak-related adverse events.
TSRL’s patch-based approach is intended to support more consistent exposure through a weekly, self-administered system.
The company said the continued funding will support preclinical development activities covering pharmacokinetics, efficacy, safety, formulation optimisation and preparation for future regulatory milestones.
“Trospium Chloride is an established therapy, but delivery matters,” said Dr Lipka.
“By developing a weekly, self-administered microneedle patch, our goal is to create a more consistent and patient-friendly option that can improve tolerability, support adherence, and generate the data needed to move this programme toward future regulatory milestones.”
Preclinical development
The second-year award builds on TSRL’s original Phase II Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH.
The grant supports advancement of the company’s hydrogel-based microneedle system for overactive bladder therapy.
TSRL is an Ann Arbor, Michigan-based preclinical contract research organisation specialising in formulation development, bioanalysis, exploratory toxicology and pharmacokinetic strategies.
More information about TSRL is available on the company’s website.
The content of the release is solely the responsibility of TSRL and does not necessarily represent the official views of the National Institutes of Health.
FAQs
What funding has TSRL received?
TSRL has received a second-year NIH Notice of Award providing nearly $1.1 million to advance its Trospium Chloride microneedle patch programme.
What condition is the patch being developed for?
The patch is being developed for overactive bladder, a condition linked to urinary urgency, frequency and incontinence.
What is Trospium Chloride?
Trospium Chloride is an antimuscarinic medicine used to treat overactive bladder symptoms by relaxing bladder muscles.
Why use a microneedle patch?
TSRL says a weekly, self-administered microneedle patch could support more consistent drug exposure, improve tolerability and make treatment easier for patients to use.
