MedPath

Tolterodine

Generic Name
Tolterodine
Brand Names
Detrol, Detrusitol
Drug Type
Small Molecule
Chemical Formula
C22H31NO
CAS Number
124937-51-5
Unique Ingredient Identifier
WHE7A56U7K
Background

Tolterodine is an antimuscarinic drug that is used to treat urinary incontinence. Tolterodine acts on M2 and M3 subtypes of muscarinic receptors.

Indication

For the treatment of overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence).

Associated Conditions
Urinary Urge Incontinence

Battery-Free Sacral Neuromodulation Device Shows 84% Success Rate in Treating Urinary Incontinence

• The Neuspera percutaneous sacral neuromodulation device demonstrated 84.2% efficacy in reducing urgent urinary leaks by at least 50% in a pivotal Phase 2 trial of 128 patients. • Among responders, 84% achieved greater than 75% reduction in UUI symptoms, while 42% experienced complete symptom elimination, with patients showing 3.5x improvement in quality of life. • The battery-free device, currently under FDA review with a decision expected in 2025, offers comparable effectiveness to traditional SNM devices while eliminating battery-related concerns.

FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH

• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). • Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need. • Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo. • Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.

FemPulse Receives FDA IDE Approval for Wearable Overactive Bladder Therapy

• FemPulse has received FDA IDE approval to begin its EVANESCE II pivotal clinical trial for its overactive bladder (OAB) therapy in women. • The FemPulse Ring, a vaginally-inserted wearable device, provides continuous neuromodulation therapy as a non-surgical alternative for OAB. • The EVANESCE II trial will compare the FemPulse Ring against first-line medication, aiming to establish it as a viable first-line treatment option. • FemPulse's technology has advanced to the final stage of regulatory approval in the EU, with potential commercial availability in 2025.
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