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Safety in Lactation: Antimigraine drugs
21 October 2020If simple analgesics, e.g. paracetamol and ibuprofen, are insufficient to treat symptoms, sumatriptan is the drug of choice for the treatment of acute migraine. Although…
Safety in Lactation: Drugs for movement disorders
10 November 2018Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Drugs for dystonias and other involuntary…
Refrigerated Storage
BotoxAllergan Ltd
Allergan Ltd
Botox
Powder for solution for injection 50, 100, 200 units/vial
In the event of an inadvertent temperature excursion the following data may be used:
There is no effect on the stability of the product if it is exposed to temperatures:
Within a range of -70°C to 30°C for a period of no more than five days (120 hours)
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
The product should be returned to the fridge as soon as possible and marked "use first" if exposed to the storage conditions specified above.
25 March 2021
London MI Service
AzzalureGalderma
Galderma
Azzalure
125 units powder for solution for injection
Contact Galderma in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
22 September 2021
London MI Service
DysportIpsen
Ipsen
Dysport
Powder for solution for injection (300units or 500units)
Contact Ipsen in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
12 November 2021
London MI Service
Lactation Safety Information
-
No published evidence of safety after therapeutic use. Botulism in a mother showed no transfer of toxin to infant via breast milk
No systemic absorption in mother if used correctly. Therefore, not expected to be found in breast milk
Delay cosmetic use until infant weaned
8 November 2018
New Medicines
Botox Treatment of lower limb muscle spasticity in children aged 2 to 17 years with cerebral palsy
Information
Botox
Licence extension / variation
AbbVie
AbbVie
Development and Regulatory status
Launched
Phase III Clinical Trials
Launched
Dec 20Licence change approved by the MHRA. The new indication is treatment of focal spasticity, including ankle and foot, in ambulant paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy [6].
Oct 19FDA approves license extension for Botulinum A toxin for treatment of lower limb spasticity in children and adolescents aged 2 to 17 years [5].
Mar 19Filed in US for treatment of lower limb spasticity aged 2 to 17 years; a decision is expected Q4 2019 [1,2].
Category
Glutamate receptor antagonist
Cerebral palsy is the most common condition associated with spasticity in children and young people, although it can also occur with other forms of nonprogressive and progressive brain disorders. The incidence of cerebral palsy is not known, but its prevalence in the UK is 186 per 100,000 population, with a total of 110,000 people affected [3,4].
Treatment of lower limb muscle spasticity in children aged 2 to 17 years with cerebral palsy
Intramuscular
Evidence based evaluations
XeominChronic sialorrhoea due to neurological disorders in children
Information
Xeomin
Licence extension / variation
Merz Pharmaceuticals
Merz Pharmaceuticals
Development and Regulatory status
Launched
Launched
Launched
September 2021
Sep 21MHRA approves licence extension for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥12 kg of chronic sialorrhea due to neurological / neurodevelopmental disorders [7].
Aug 21Approved in the EU using the EU Mutual Recognition procedure [8].
Dec 20FDA approves a supplemental Biologics License Application (sBLA) for botulinum toxin A (Xeomin) for the treatment of patients aged 2 years and older with chronic sialorrhea. Xeomin is the first and only FDA-approved neuromodulator with this indication and was granted a priority review designation upon acceptance by the FDA [6].
Jul 18Will be filed in the EU using the mutual recognition procedure [2].
Category
Glutamate receptor antagonist
Prevalence of moderate-to-severe drooling in children, young people and adults with neurological conditions, particularly cerebral palsy, is estimated to be between 10% and 37% [1].
Chronic sialorrhoea due to neurological disorders in children
Intramuscular
Trial or other data
Nov 20No update to PIII trial (NCT02270736) registry; still no results available [5].
Jul 19PIII trial (NCT02270736) completed May 19; no results posted [4].
Jun 18PIII trial (NCT02270736) is active but has completed recruitment. No results posted yet [3].
Dec 14PIII trial to assess the safety and efficacy of botulinum toxin A in children and adolescents for the treatment of chronic troublesome sialorrhoea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability starts (SIPEXI; NCT02270736). 249 patients, aged 2 to 17 years old, will be recruited in Georgia, Hungary, Poland, Russia and Serbia. This trial contains an open-label extension period. Primary outcomes are change in unstimulated salivary flow rate [uSFR] from baseline to Week 4 (for subjects aged 6-17 years only. uSFR: weighing of dental rolls soaked with saliva over 5 minutes; procedure repeated after 30 minutes. The reduction of measured weight over the study relates to improvement of sialorrhea), Global Impression of Change Scale [GICS] at Week 4 representing the functional improvement in drooling since baseline as assessed by the carer/parent(s), and occurrence of treatment emergent AEs. Collection of these data are due to complete Feb 18 [3].
Evidence based evaluations
Botox Treatment of upper limb muscle spasticity in children aged 2 to 17 years with cerebral palsy
Information
Botox
Licence extension / variation
AbbVie
AbbVie
Development and Regulatory status
Launched
Phase III Clinical Trials
Launched
May 2022
May 22MHRA approves a new indication for Botox, for the symptomatic treatment of focal spasticity, including elbow, wrist and hand in paediatric cerebral palsy patients, two years of age or older as an adjunct to rehabilitative therapy [5].
Jun 19Approved in US for treatment of upper limb spasticity in children aged 2 to 17 years [1].
Category
Glutamate receptor antagonist
Cerebral palsy is the most common condition associated with spasticity in children and young people, although it can also occur with other forms of nonprogressive and progressive brain disorders. The incidence of cerebral palsy is not known, but its prevalence in the UK is 186 per 100,000 population, with a total of 110,000 people affected [2,3].
Treatment of upper limb muscle spasticity in children aged 2 to 17 years with cerebral palsy
Intramuscular
Trial or other data
Sep 18Allergan complete PIII trial (NCT01603615) of Botox for treatment of pediatric upper limb spasticity. A second PIII study (NCT01603602) completed June 17 [4].
DysportTreatment of urinary incontinence in patients with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis
Information
Dysport
Licence extension / variation
Ipsen
Ipsen
Development and Regulatory status
Launched
Recommended for approval (Positive opinion)
Pre-registration (Filed)
July 2022
Jul 22The EU positive opinion for Dysport permits individual European country Health Authorities to grant national approvals, according to their country regulations [6].
Jul 22MHRA approves new indication for Dysport 300unit and 500unit vials, for the management of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who are regularly performing clean intermittent catheterisation [5].
Jun 22Dysport receives positive opinion in Europe for the management of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who are regularly performing clean intermittent catheterisation. The submission based on data from the pivotal international PIII CONTENT clinical program [6].
Jul 21Currently pre-registration; location not stated but presume UK, EU and US (based on previous regulatory activity) [4].
Category
Glutamate receptor antagonist. 600U (start dose) or 800U (highest dose) per treatment session, dosed no more frequently than every 12 weeks.
60-80% of people with MS and 75-80% of people with spinal cord injury will have some degree of bladder dysfunction including urinary incontinence [1].
Treatment of urinary incontinence in patients with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis
Intramuscular
Trial or other data
Oct 20Publication of results from PIII CONTENT1 and CONTENT2 studies are expected Q1 21 [3].
Nov 19Both PIII trials, CONTENT1 and CONTENT2, have been terminated due to low recruitment [2].
Jun 16PIII CONTENT2 study to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS) starts (NCT02660359). 258 adults will be recruited in countries including the UK and EU. Primary outcome is change in weekly number of UI episodes after 6 weeks; collection of these data is due to complete Nov 18 [2].
Mar 16PIII CONTENT1 study to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS). starts (NCT02660138). 227 adults will be recruited in countries including the US and EU. Primary outcome is change in weekly number of UI episodes after 6 weeks; collection of these data is due to complete Nov 18 [2].
XeominLower limb muscle spasticity following stroke or traumatic brain injury - first-line in adults
Information
Xeomin
Licence extension / variation
Merz Pharmaceuticals
Merz Pharmaceuticals
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Glutamate receptor antagonist
In England, approximately 110,000 people have a stroke each year and between 19 and 38% of them (up to 41,800 people) are affected by spasticity. Of the people who have spasticity associated with stroke, 79% report spasticity in the elbow, 66% report spasticity in the wrist, 50% report spasticity in the hip, 54% report spasticity in the knee, and 66% report spasticity in the ankle [1].
Lower limb muscle spasticity following stroke or traumatic brain injury - first-line in adults
Intramuscular
Further information
Yes
XeominTreatment of lower limb muscle spasticity in children and adolescents aged 2 to 17 years
Information
Xeomin
Licence extension / variation
Merz Pharmaceuticals
Merz Pharmaceuticals
Development and Regulatory status
Discontinued
Discontinued
Discontinued
Jun 22Development discontinued as primary efficacy endpoint did not show statistical significance between the dose groups in PIII trial [5].
Category
Glutamate receptor antagonist
Pooled data from five active cerebral palsy registers in the UK suggest a mean annual prevalence rate for normal birth-weight children of 1.2 per 1,000 live births [3].
Treatment of lower limb muscle spasticity in children and adolescents aged 2 to 17 years
Intramuscular