Botulinum toxin type A for injection PH. EUR.

What is on this page?

• What is botulinum toxin type A for injection PH. EUR.?
• How does botulinum toxin type A work?
• Which conditions is it used or studied for?
• How is botulinum toxin type A given?
• What do the clinical trials show?
• What side effects are known?

What is botulinum toxin type A for injection PH. EUR.?

Botulinum toxin type A for injection PH. EUR. is a protein-based substance classified as botulinum toxin (ATC code M03AX01). It appears in the trial records under the product names Vistabel 4 Allergan units/0.1 ml powder for solution for injection and the FTP-002/FTP-501 combination.^[1] The substance is already authorised as a medicine in Germany, with authorisation held by AbbVie Limited and Fastox Pharma SA.^[1] In the registered trial, the substance serves both as the test product (as part of the combination) and as a comparator (as Vistabel).^[1]

How does botulinum toxin type A work?

Botulinum toxin type A is a muscle-relaxing substance. NHS formulary sources describe it as a treatment that acts on involuntary muscle movements and related conditions, which reflects its ability to reduce muscle activity where injected.^[2][3] In glabellar lines, the aim of treatment is to relax the small muscles between the eyebrows that create frown lines.

Which conditions is it used or studied for?

• Glabellar lines — the vertical frown lines between the eyebrows, which were the condition studied in the registered trial.^[1]
• Blepharospasm and hemifacial spasm — involuntary eyelid or facial muscle spasms, listed in NHS formulary sources for botulinum toxin type A brands.^[2][3]
• Cervical dystonia — painful involuntary neck muscle contractions, also listed in formulary sources.^[2][3]
• Focal spasticity — muscle stiffness in a limited part of the body, listed for botulinum toxin type A brands.^[2]
• Chronic migraine — botulinum toxin type A is listed for migraine prevention in line with NICE guidance.^[2][3]
• Chronic sialorrhoea — excessive drooling, listed in formulary sources.^[3]
• Overactive bladder — listed in formulary sources for botulinum toxin type A.^[2]

How is botulinum toxin type A given?

Botulinum toxin type A for injection PH. EUR. is given by injection. The registered pharmaceutical forms are powder for solution for injection and solution for injection.^[1] In the trial, one single intramuscular injection of the FTP-501 component or the FTP-002/FTP-501 combination was evaluated in participants with severe glabellar lines.^[1] NHS formulary sources list botulinum toxin type A as an injection, with strengths such as 100 units per vial for Botox and 300 units per vial for Dysport.^[3]

What do the clinical trials show?

One completed Phase 1/2 trial (EU CT number 2023-507249-27-00) investigated the FTP-002/FTP-501 combination in 116 participants with severe glabellar lines.^[1] Part 1 evaluated the tolerability and safety of a single intramuscular injection of FTP-501 alone. Part 2 evaluated the safety and tolerability of the FTP-002/FTP-501 combination compared with FTP-002 alone.^[1]

The trial measured responder rates using two scales: the Investigator's Live Assessment (ILA) and the Subject's Self-Assessment (SSA), both at maximum frown and at rest. Responders were defined as participants with at least one or two grades of improvement from baseline. The trial also measured the duration of treatment response, from the day of injection until the frown line score returned to its starting level.^[1]

The study also included a sodium chloride injection arm and a Vistabel arm as comparators.^[1] Because the trial is completed, results may be available from the registry record.

What side effects are known?

The provided sources do not describe side effects for botulinum toxin type A in detail. NHS formulary entries list the substance for specialist use and note that brands are not interchangeable, but they do not give a side-effect profile in the supplied content.^[2][3]