Introduction
SANCTURA XR, a formulation of trospium chloride, is an extended-release capsule indicated for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and urinary frequency. Here, we will delve into the clinical trials, market analysis, and projections for this medication.
Clinical Trials Overview
SANCTURA XR has undergone extensive clinical testing to evaluate its efficacy and safety.
Phase 3 Clinical Trials
In two Phase 3 trials, SANCTURA XR was administered to patients with OAB. These studies included 591 patients aged 21 to 90 years, with 86% being female and 85% Caucasian. Patients received a daily dose of 60 mg of SANCTURA XR. The trials allowed patients to continue unblinded treatment with SANCTURA XR for up to one year[1][4].
Efficacy and Safety Findings
The trials demonstrated significant improvements in OAB symptoms. The most common treatment-emergent adverse events (TEAEs) were dry mouth and constipation, which often occurred early in treatment. These side effects led to discontinuation in 1%, 0.7%, and 0.5% of patients treated with SANCTURA XR for constipation, dry mouth, and urinary retention, respectively[1][4].
Adverse Events
In addition to dry mouth and constipation, other common TEAEs included dry eye, flatulence, nausea, abdominal pain, dyspepsia, and urinary tract infections. Less common adverse events (<1%) included tachycardia, palpitations, vision blurred, and eye irritation[1][4].
Market Analysis
Launch and Market Presence
SANCTURA XR was launched in the U.S. in January 2008 by Allergan and Indevus Pharmaceuticals. Indevus also licensed the rights to market SANCTURA XR in various territories outside the U.S., including a joint agreement with Rottapharm Madaus Group for Canada[5].
Market Performance
Since its launch, SANCTURA XR has shown solid market performance. While specific sales figures for SANCTURA XR alone are not detailed in the available sources, the broader context of the pharmaceutical market indicates a growing demand for treatments of overactive bladder. The market for OAB treatments is significant, with many patients seeking relief from symptoms that can significantly impact their quality of life[3].
Market Projections
Market Size and Growth
The market for OAB treatments is substantial and growing. As the population ages, the prevalence of OAB is expected to increase, driving demand for effective treatments. The combined target market for OAB and related conditions is projected to be in the billions of dollars, with SANCTURA XR positioned as a key player in this segment[2].
Competitive Landscape
SANCTURA XR operates in a competitive market with other antimuscarinic and anticholinergic medications. However, its extended-release formulation and relatively favorable side effect profile make it an attractive option for patients and healthcare providers. The drug's effectiveness and tolerability, as demonstrated in clinical trials, contribute to its market appeal[3].
Patient Discontinuation Rates
One of the critical factors in the market success of any medication is patient adherence. SANCTURA XR has shown lower discontinuation rates compared to some other medications in its class. For instance, dry mouth, a common side effect, was reported in 10.7% of patients treated with SANCTURA XR, which is approximately half the rate seen with the immediate-release formulation of trospium chloride[3].
Regulatory and Patent Status
SANCTURA XR has received regulatory approval in several regions, including the U.S. and Canada. Indevus Pharmaceuticals announced the issuance of a U.S. patent for SANCTURA XR in 2008, which helps protect its market position[5].
Key Takeaways
- Clinical Efficacy: SANCTURA XR has demonstrated significant improvements in OAB symptoms in clinical trials.
- Safety Profile: Common side effects include dry mouth and constipation, with a relatively low discontinuation rate.
- Market Presence: Launched in 2008, SANCTURA XR has established itself in the U.S. and other territories.
- Market Projections: The growing demand for OAB treatments positions SANCTURA XR for continued market growth.
- Competitive Advantage: Its extended-release formulation and favorable side effect profile make it a competitive option.
Frequently Asked Questions (FAQs)
What is SANCTURA XR used for?
SANCTURA XR is used for the treatment of overactive bladder symptoms, including urge urinary incontinence, urgency, and urinary frequency.
What are the common side effects of SANCTURA XR?
Common side effects include dry mouth, constipation, dry eye, flatulence, nausea, and abdominal pain.
How does SANCTURA XR compare to other OAB medications?
SANCTURA XR has a relatively favorable side effect profile and lower discontinuation rates compared to some other medications in its class.
Is SANCTURA XR available in all regions?
SANCTURA XR is available in the U.S. and several other territories, including Canada, but its availability may vary in other regions.
What is the dosage of SANCTURA XR?
The recommended dosage is 60 mg once daily.
Sources:
- SANCTURA XR - (trospium chloride) extended release capsules 60 mg. PDF.
- Supernus Pharmaceuticals. PDF.
- Allergan Inc. Announces Agreement to Acquire Esprit Pharma. Biospace.
- SANCTURA XR (trospium chloride) capsules label. FDA.
- Indevus Pharmaceuticals Announces Issuance of U.S. Patent for SANCTURA XR(TM). FierceBiotech.
