Delving into the Latest Updates on Tolterodine Fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

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

Urinary Incontinence, Urge

Originator Organization

Pfizer Inc.

Active Organization

Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd.

Inactive Organization

Pfizer Inc.

Drug Highest PhaseApproved

First Approval Date

CN (09 Dec 2005),

Urinary Bladder, Overactive

Regulation-

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Structure/Sequence

Molecular FormulaC26H35NO5

InChIKeyHKTZTYRSKPLEIQ-BOQYJDHWSA-N

CAS Registry615254-93-8

ObjectivesThe aims of this study were to compare 12-week outcomes of single-therapy tolterodine (Detrol LA) extended release to intravaginal estrogen (Estrace) for overactive bladder (OAB) symptoms and characterize 24- and 52-week outcomes in women undergoing combined therapy.MethodsA single-site randomized, open-label trial in women with urinary frequency, urgency, nocturia, and/or urgency urinary incontinence symptoms was performed. Fifty-eight participants were randomized to oral tolterodine extended release daily or intravaginal estradiol cream nightly for 6 weeks then twice per week. The primary outcome was change in Overactive Bladder Questionnaire (OAB-q) symptom bother score at 12 weeks. Secondary outcomes included the Health-Related Quality of Life Questionnaire (HRQL) of the OAB-q and a 3-day bladder diary. At 12 weeks, subjects were offered addition of the alternative therapy with follow-up at 24 and 52 weeks.ResultsThere was no difference in symptom bother score improvement between the tolterodine and intravaginal estradiol groups baseline to 12 weeks (20.6 ± 21.7, −15.8 ± 23.3, respectively, P = 0.45). There was a significant within-group decrease in symptom bother score from baseline to 12 weeks (tolterodine, P < 0.0001, and intravaginal estradiol, P = 0.002). Secondary outcome improvement within groups was noted in the HRQL total, urinary incontinence episodes, and median voiding frequency (all P ≤ 0.03) in the tolterodine group and in the HRQL total score (P = 0.03) in the intravaginal estradiol group, with no differences between groups. Combined therapy outcomes at 24 and 52 weeks compared with single therapy at 12 weeks revealed significant improvement in symptom bother score in the intravaginal estradiol + tolterodine group at 24 and 52 weeks (20.0 ± 23.9, P = 0.008; −16.7 ± 23.3, P = 0.02, respectively).ConclusionsSignificant within-group improvement in OAB-q symptom bother was noted in both the intravaginal estradiol and tolterodine groups for OAB symptoms, with no difference between groups. Greater improvement from 12-week single therapy to 24 and 52 weeks of combined therapy was noted in the group originally assigned to intravaginal estradiol. The role of combined medical therapy for OAB symptoms needs further investigation.

01 Jul 2006·Der UrologeQ4 · MEDICINE

Vergleich der Effektivität und Verträglichkeit von Solifenacin und Tolterodin retard in der Behandlung der überaktiven Blase

Q4 · MEDICINE

Article

Author: Goepel, M

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	CN	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 Incontinence, Urge	Phase 1	US	Pfizer Inc.	01 Sep 2005
Urinary Bladder, Overactive	Phase 1	KR	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)	gzaouqqmmu(zkmsqkinxp) = jxipmsnrqk gcjknxxrpr (pryghavgka, vceaahrlja - awctutvgpn) View more	-	10 Jul 2019
				Tamsulosin+Tolterodine ER (Tamsulosin Plus Tolterodine ER 7-day Treatment)	gzaouqqmmu(zkmsqkinxp) = hantraslsf gcjknxxrpr (pryghavgka, osnobqmpna - xieflplavg) View more
NCT02138747 (PREFER, CTgov)	Phase 4	Urinary Bladder, Overactive	376	Mirabegron+Tolterodine ER (AB: Mirabegron/Tolterodine ER)	mfpeenibvz(btksgrxnfr) = cecnsmpxgl ndacxbbmaq (ordnxxwojb, mptzoomrdu - boqwxtbavp) View more	-	14 Feb 2017
				Mirabegron+Tolterodine ER (BA: Tolterodine ER /Mirabegron)	mfpeenibvz(btksgrxnfr) = huvtdtwqoo ndacxbbmaq (ordnxxwojb, smkvnxmojp - amntlrzhtp) View more
NCT01530243 (CTgov)	Phase 2/3	Complication \| Urologic Diseases	104	Placebo (Placebo)	fucuvzujfe(cjzoslubla) = qghzpufgyn piziorzeji (wvhmjifxmt, tsvtnwwfwi - mjyvjnmase) View more	-	02 Mar 2015
				Terazosine (Terazosin)	fucuvzujfe(cjzoslubla) = yyamuamjjn piziorzeji (wvhmjifxmt, znlhrxrptu - adlfdnwnot) View more
NCT00323635 (CTgov)	Phase 4	Urinary Incontinence \| Nocturia	19	tolterodine (Tolterodine)	ghyhzkkxuz(tfielcbnky) = ykfbsjpxeq kfokikjgme (auhafrzwxn, eqwzstaxff - bpvinukrji) View more	-	04 Dec 2014
				tolterodine (Placebo)	ghyhzkkxuz(tfielcbnky) = fjuuppalev kfokikjgme (auhafrzwxn, yseoxzqerk - jgrmcoxpbn) View more
NCT00465894 (DRIVE, CTgov)	Not Applicable	Overactive bladder syndrome	58	Extended Release Tolterodine LA	nfxbwtuygw(beewmwseft) = wcmqtwhdsk jlumbbopwq (tdmyrvpwxj, aveqgszxcl - acxnwomzle) View more	-	23 Oct 2012