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Safety in Lactation: Drugs for urinary frequency, enuresis, and incontinence

25 September 2020This group of drugs have varied mechanisms of action in treating urinary control conditions. Indications are broadly similar for all drugs, although there are small…

Drugs for urinary disorders – are any lactose-free?

5 February 2020This Medicine Q&A gives details of available urinary frequency, enuresis, incontinence and urinary retention preparations that do not contain lactose. There is a lactose-free preparation…
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Medicine Compliance Aid Stability

BetmigaAstellas Pharma Ltd

Astellas Pharma Ltd
Betmiga
Tablets m/r 25mg, 50mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from moisture
Protect from moisture in an airtight container.
21 September 2015

Lactation Safety Information

Oxybutynin
Long half-life increases risk of accumulation in breastfed infants
No published evidence of safety
22 September 2020

New Medicines

Betmiga (EU) Myrbetriq (US)Neurogenic detrusor overactivity in children aged 3 to 17 years

Information

Betmiga (EU) Myrbetriq (US)
Licence extension / variation
Astellas
Astellas

Development and Regulatory status

None
Phase III Clinical Trials
Launched
Mar 21Approved in US for treatment of neurogenic detrusor overactivity in children ≥3 years [10].
Sep 20Filed in the US; still PIII in EU [9].
Oct 19Filings have not yet been made [8].
May 16PIII study starts [1].

Category

Beta 3 receptor agonist
The incidence of the problem is reported as 8.4% in girls and 1.7% in boys [3].
Neurogenic detrusor overactivity in children aged 3 to 17 years
Oral

Trial or other data

Apr 20Astellas Pharma initiates PIII Crocodile trial to assess safety, efficacy and pharmacokinetics of mirabegron prolonged-release tablet (25mg or 50mg) in paediatric patients (aged 5 to 17 years) with neurogenic detrusor overactivity on clean intermittent catheterisation (178-CL-206A; EudraCT2015-002876-25). The open-label, dose-titration, baseline-controlled trial is recruiting 63 patients in Lithuania, and will extend to Australia, Belgium, Brazil, Colombia, Costa Rica, Denmark, Egypt, Israel, Jordan, South Korea, Malaysia, Mexico, Norway, Philippines, Poland, Romania, Saudi Arabia, Serbia, Slovakia, Taiwan and Turkey [2].
May 19PIII Crocodile trial (NCT02751931) completes [7].
Dec 18PIII (NCT02751931) study recruitment stopped; data still due Feb 19 [6].
Sep 17PIII Crocodile trial (NCT02751931) is still recruiting. Collection of primary outcome data now expected to complete Feb 19 [5].
Jan 17PIII Crocodile trial (NCT02751931) is currently recruiting patients. Estimated primary completion date August 2019 [4].

Betmiga (EU) Myrbetriq (US)Overactive bladder in children aged 5 to 17 years

Information

Betmiga (EU) Myrbetriq (US)
Licence extension / variation
Astellas
Astellas

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Beta 3 receptor agonist
According to two fairly recent, large-scale studies, the prevalence of OAB in children is in the 15–20% range. Those studies both reported a higher prevalence of OAB in boys. Chung et al noted a decreasing prevalence of OAB with age, from 23.0% at five years old down to 12.2% at 13 years old [1].
Overactive bladder in children aged 5 to 17 years
Oral