Delving into the Latest Updates on Tolterodine Fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

M2 receptor x M3 receptor

Action

antagonists

Mechanism

M2 receptor antagonists(Muscarinic acetylcholine receptor M2 antagonists), M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Urinary Bladder, Overactive

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd.

Inactive Organization

Pfizer Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (09 Dec 2005),

Urinary Bladder, Overactive

Regulation-

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Structure/Sequence

Molecular FormulaC26H35NO5

InChIKeyHKTZTYRSKPLEIQ-BOQYJDHWSA-N

CAS Registry615254-93-8

ImportanceStrong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.ObjectiveThe aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.Study DesignThis cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).ResultsOne thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.ConclusionsBeta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

01 Mar 2018·Neurourology and Urodynamics

Comparative efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents in overactive bladder: A systematic literature review and network meta‐analysis

Review

Author: Odeyemi, Isaac ; Aballéa, Samuel ; Nazir, Jameel ; Maman, Khaled ; Mankowski, Colette ; Hakimi, Zalmai ; Kelleher, Con

AimsTo compare efficacy and tolerability of solifenacin 5 mg/day versus other oral antimuscarinic agents for the treatment of overactive bladder (OAB).MethodsLiterature searches of MEDLINE, Embase, and the Cochrane Library were undertaken to identify randomized controlled trials in OAB (2000‐2015) for antimuscarinic agents. A network meta‐analysis (NMA) was performed to estimate efficacy and tolerability outcomes for solifenacin 5 mg/day relative to other antimuscarinics.ResultsThe NMA included 53 eligible trials (published, n = 48; unpublished on search date, n = 5). Solifenacin 5 mg/day was significantly more effective than tolterodine 4 mg/day for reducing incontinence and urgency urinary incontinence (UUI) episodes, but significantly less effective than solifenacin 10 mg/day for micturition; no other statistically significant differences were noted for efficacy. Solifenacin 5 mg/day had a statistically significant lower risk of dry mouth compared with darifenacin 15 mg/day, fesoterodine 8 mg/day, oxybutynin extended‐release 10 mg/day, oxybutynin immediate‐release (IR) 9‐15 mg/day, tolterodine IR 4 mg/day, propiverine 20 mg/day, and solifenacin 10 mg/day. There were no significant differences between solifenacin 5 mg/day and other antimuscarinics for risk of blurred vision, or for 11 of 17 active comparators for risk of constipation.ConclusionsThis NMA suggests that the efficacy of solifenacin 5 mg/day is at least similar to other common antimuscarinics across the spectrum of OAB symptoms analyzed, and is more effective than tolterodine 4 mg/day in reducing incontinence and UUI episodes. Solifenacin 5 mg/day has a lower risk of dry mouth compared with several agents.

01 Dec 2016·Journal of Medical EconomicsQ4 · MEDICINE

Mirabegron for the treatment of overactive bladder: cost-effectiveness from US commercial health-plan and Medicare Advantage perspectives

Q4 · MEDICINE

Article

Author: Campbell, Noll L. ; Klein, Timothy M. ; Wielage, Ronald C. ; Klein, Robert W. ; Posta, Linda M. ; Yuran, Thomas ; Ng, Daniel B. ; Perk, Sinem

BACKGROUND AND OBJECTIVEThe first class of oral pharmacologic treatments for overactive bladder (OAB) are antimuscarinics that are associated with poor persistence, anticholinergic adverse events, and increased anticholinergic burden (ACB) with risk of cognitive impairment. Mirabegron, a β3-adrenoceptor agonist, is an oral treatment that does not contribute to ACB and has early evidence of improved persistence. The objective of the analysis was to assess the cost-effectiveness of mirabegron for OAB vs six antimuscarinics in the US.METHODSA Markov state-transition model assessed US commercial health-plan and Medicare Advantage perspectives over a 3-year time horizon in an OAB patient population. Transition probabilities between five micturition and five incontinence severity states were derived from a network meta-analysis of 44 trials of oral OAB treatments. Therapy beginning with an oral OAB agent could discontinue or switch to another oral agent and could be followed by tibial nerve stimulation, sacral neuromodulation, or onabotulinumtoxinA. The primary outcome was cost per quality-adjusted life year (QALY). Utilities were mapped from incontinence and micturition frequencies as well as demographics. Based on analysis of data from a large healthcare system, elevated ACB was associated with increased healthcare utilization and probability of cognitive impairment.RESULTSFrom both commercial and Medicare Advantage perspectives, mirabegron was the most clinically effective treatment, while oxybutynin was the least expensive. Tolterodine immediate release (IR) was also on the cost-effectiveness frontier. The analysis estimated costs per QALY of $59,690 and $66,347 for mirabegron from commercial health plan and Medicare Advantage perspectives, respectively, compared to tolterodine IR. Other antimuscarinics were dominated.CONCLUSIONSThis analysis estimated that mirabegron is a cost-effective treatment for OAB from US commercial health plan and Medicare Advantage perspectives, due to fewer projected adverse events and comorbidities, and data suggesting better persistence.

100 Deals associated with Tolterodine Fumarate

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Urinary Bladder, Overactive	China	Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd.	09 Dec 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Bladder, Overactive	Phase 1	South Korea	Pfizer Inc.	01 Mar 2003

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01741454 (CTgov)	Phase 4	Urinary tract obstruction \| Ureteral Obstruction \| Lower Urinary Tract Symptoms	181	Tamsulosin (Tamsulosin Plus Placebo 7-day Treatment)	tmoduoebwd(oeuhmwngvo) = svovwadkyg gcsfcwhmzm (kktltrechq, gkabuiojyz - xjcpljvaiz) View more	-	10 Jul 2019
				Tamsulosin+Tolterodine ER (Tamsulosin Plus Tolterodine ER 7-day Treatment)	tmoduoebwd(oeuhmwngvo) = ktcwfhvbse gcsfcwhmzm (kktltrechq, kkvfhebgdp - zptqkqhouc) View more
NCT02138747 (PREFER, CTgov)	Phase 4	Urinary Bladder, Overactive	376	Mirabegron+Tolterodine ER (AB: Mirabegron/Tolterodine ER)	cdyfbesudi(fxnhnmefew) = lolowricrw okgbmhbrqe (lrwbplkctk, sgasblbqds - zigrpjjuwa) View more	-	14 Feb 2017
				Mirabegron+Tolterodine ER (BA: Tolterodine ER /Mirabegron)	cdyfbesudi(fxnhnmefew) = wckgjmotau okgbmhbrqe (lrwbplkctk, anrujvxvmw - umehvwvmqu) View more
NCT01530243 (CTgov)	Phase 2/3	Complication \| Urologic Diseases	104	Placebo (Placebo)	hnsfnxsktb(tqsibktmmd) = qoesyierfw fvuxexnysw (nvqrroopsb, obiizltzic - cynfaraixm) View more	-	02 Mar 2015
				Terazosine (Terazosin)	hnsfnxsktb(tqsibktmmd) = ocijcznmou fvuxexnysw (nvqrroopsb, mhtspsvvqw - exjyfkrjqs) View more