565 Phase 3 Efficacy and Safety of Once-Monthly Oxybutynin Vaginal Ring Delivering 4 Mg/Day or 6 Mg/Day vs Placebo Ring in Women With Urge Incontinence, Frequency, and Urgency Symptoms of Overactive Bladder

Swierzewski, Mark J.; Seidman, Larry; Dasen, Sue; Weiss, Herman

doi:10.1016/j.juro.2013.02.1961

Cited by 2 publications

(3 citation statements)

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“…The device was well tolerated by all participants throughout the study. Efficacy and tolerability of intravaginal oxybutynin (4 mg and 6 mg vs. placebo vaginal ring) have previously been demonstrated, with dry mouth being the one of the most commonly reported AEs (Swierzewski et al., 2013 ). Plasma concentration profiles obtained with MedRing were similar to orally administered oxybutynin (typical oral dose 5–15 mg; AUC inf >8 h ng/mL/mg) (Douchamps et al., 1988 ; Yarker et al., 1995 ).…”

Section: Discussionmentioning

confidence: 94%

“…Although N -desethyloxybutynin-related adverse events (AEs) are reduced with these alternative formulations, local skin reactions are still observed (Davila, 2006 ; Starkman & Dmochowski, 2006 ; MacDiarmid, 2009 ; Gomelsky & Dmochowski, 2012 ). Intravaginal delivery of oxybutynin using a once-monthly vaginal ring delivering 4 or 6 mg/day demonstrated efficacy and tolerability in a multicenter, 12-week phase 3 trial (Swierzewski et al., 2013 ). Oxybutynin can cause AEs when taken orally, including dry mouth, constipation, drowsiness, and blurred vision (Yarker et al., 1995 ; Jirschele & Sand, 2013 ; Yamada et al., 2018 ).…”

Section: Introductionmentioning

confidence: 99%

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First-in-human study to assess the pharmacokinetics, tolerability, and safety of single-dose oxybutynin hydrochloride administered via a microprocessor-controlled intravaginal ring

Laat¹,

Pagan

Malcolm

et al. 2023

Drug Delivery

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Polymeric drug-releasing vaginal rings are useful for both local and systemic administration of drugs via the intravaginal route. Typically, they provide continuous sustained or controlled release of drug(s) over extended time periods, thereby avoiding overdose and improving adherence. This first-in-human study (EudraCT number: 2020-0050044-30) evaluated the pharmacokinetics, safety, and tolerability of a single dose of oxybutynin administered by a novel microprocessor-controlled vaginal ring (MedRing). Eight healthy female subjects received an electronically controlled single intravaginal dose of 3 mg oxybutynin hydrochloride (100 mg/mL) dissolved in 1:1 water/propylene glycol administered via MedRing. Following dosing, MedRing was kept in situ for up to 6 h. Blood samples were collected 1 h prior to oxybutynin dosing and subsequently at regular intervals post-dose for the assessment of plasma concentrations of oxybutynin and its active metabolite N -desethyloxybutynin. The results showed that MedRing efficiently administered oxybutynin via the intravaginal route, resulting in plasma oxybutynin levels comparable to orally administered oxybutynin. The mean ± standard deviation pharmacokinetic parameters for oxybutynin were C max 5.4 ± 2.7 ng/mL, AUC inf 34.9 ± 17.4 h ng/mL, t 1/2 8.5 ± 3.5 h and for N-desethyloxybutynin were C max 3.9 ± 2.5 ng/mL, AUC inf 51.1 ± 43.1 h ng/mL, t 1/2 7.7 ± 5.9 h. No serious adverse events were reported. The study demonstrates that intravaginal administration of oxybutynin hydrochloride using the MedRing device was well tolerated.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

First-in-human study to assess the pharmacokinetics, tolerability, and safety of single-dose oxybutynin hydrochloride administered via a microprocessor-controlled intravaginal ring

Laat¹,

Pagan

Malcolm

et al. 2023

Drug Delivery

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“…In fact, dry mouth occurred in 6% of cases with DR-3001 4 mg/d, 8% with DR-3001 6 mg/d, and 4% with placebo; constipation occurred in 1%, 1%, and 2% of cases with DR-3001 4 mg/d, DR-3001 6 mg/d, and placebo, respectively; culture-positive UTIs occurred in 8%, 10%, and 8% of cases with DR-3001 4 mg/d, DR-3001 6 mg/d, and placebo, respectively. 32 …”

Section: Targeted Bladder Ddssmentioning

confidence: 99%

Novel targeted bladder drug-delivery systems: a review

Zacchè¹,

Srikrishna²,

Cardozo³

2015

RRU

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The objective of pharmaceutics is the development of drugs with increased efficacy and reduced side effects. Prolonged exposure of the diseased tissue to the drug is of crucial importance. Drug-delivery systems (DDSs) have been introduced to control rate, time, and place of release. Drugs can easily reach the bladder through a catheter, while systemically administered agents may undergo extensive metabolism. Continuous urine filling and subsequent washout hinder intravesical drug delivery (IDD). Moreover, the low permeability of the urothelium, also described as the bladder permeability barrier, poses a major challenge in the development of the IDD. DDSs increase bioavailability of drugs, therefore improving therapeutic effect and patient compliance. This review focuses on novel DDSs to treat bladder conditions such as overactive bladder, interstitial cystitis, bladder cancer, and recurrent urinary tract infections. The rationale and strategies for both systemic and local delivery methods are discussed, with emphasis on new formulations of well-known drugs (oxybutynin), nanocarriers, polymeric hydrogels, intravesical devices, encapsulated DDSs, and gene therapy. We give an overview of current and future prospects of DDSs for bladder disorders, including nanotechnology and gene therapy.

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565 Phase 3 Efficacy and Safety of Once-Monthly Oxybutynin Vaginal Ring Delivering 4 Mg/Day or 6 Mg/Day vs Placebo Ring in Women With Urge Incontinence, Frequency, and Urgency Symptoms of Overactive Bladder

Cited by 2 publications

References 0 publications

First-in-human study to assess the pharmacokinetics, tolerability, and safety of single-dose oxybutynin hydrochloride administered via a microprocessor-controlled intravaginal ring

First-in-human study to assess the pharmacokinetics, tolerability, and safety of single-dose oxybutynin hydrochloride administered via a microprocessor-controlled intravaginal ring

Novel targeted bladder drug-delivery systems: a review

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