ALLUZIENCE Solution for injection Ref.[50428] Active ingredients: Botulinum toxin type A

Pharmacotherapeutic group: Other muscle relaxants, peripherally acting agents
ATC code: M03AX01

Mechanism of action

The primary pharmacodynamic effect of botulinum toxin type A is chemical denervation of the treated muscle, resulting in a measurable decrease of the compound muscle action potential. This causes a localized reduction of muscle activity.

Botulinum toxin type A is a muscle relaxant that temporarily weakens muscle activity. After injection, botulinum toxin type A works by blocking the transport of the neurotransmitter acetylcholine across the neuromuscular junction, located between the nerve end and the muscle fibre. The mode of action involves four main stages, all of which must function correctly for activity to occur. The action results in stopping contraction of the targeted muscles. The effect lasts for sustained periods until the junction has recovered and muscle activity returns.

Clinical efficacyand safety

A pooled total of 372 patients with moderate to severe glabellar lines were treated in 2 pivotal trials, 250 at the recommended dose of 50 Speywood units, and 122 with placebo.

The majority of patients subjectively reported an effect within 2 to 3 days, including 23% of patients within 1 day. The proportion of responders by investigator assessment was statistically significantly higher for patients treated with Alluzience 1 month after injection compared to placebo (the primary endpoint) as well as at all other timepoints from 8 days up to 6 months (Table 2).

Table 2. Investigator Live Assessment at Maximum Frown – Responder Rate (%) at different time points:

Note: A responder is defined as having a severity grade of moderate or severe at baseline and a severity grade of none or mild at a given visit.

Responder rate, the primary efficacy endpoint at Day 29, was statistically significantly different to placebo (p<0.0001).

Responder rates at other time points were nominally different to placebo (p-values ranging from ≤ 0.0001 to 0.0008).

The proportion of responders according to the patient self-assessment was higher for patients treated with Alluzience compared to placebo at all timepoints from 8 days up to 6 months (Table 3).

Table 3. Patient Self-Assessment – Responder Rate (%) at different time points:

Note: A responder is defined as having a severity grade of moderate or severe at baseline and a severity grade of none or mild at a given visit

Responder rates were nominally different to placebo with p≤0.0001 at all time points.

Patients' level of satisfaction 1 month following injection showed that 85.2% of the patients receiving Alluzience were either satisfied or very satisfied compared to 9% for placebo patients.

Aesthetic and psychological improvement was observed using Face-Q scales. For the facial appearance overall scale (which incorporates subject ratings for facial balance, end-of-day appearance, facial freshness, rested look, appearance when waking up and appearance under bright lights) and the psychological wellbeing scale (which incorporates subject ratings on feeling okay, self-acceptance, comfort with self, feeling good, self-liking, feeling happy, feeling attractive, and feeling confident), one month after injection, subjects treated with Alluzience showed improvement in the score for each of these scales compared to subjects who were treated with placebo (nominal p<0.0001).

A total of 595 patients received up to 5 treatment cycles of Alluzience in a 12 months long-term open-label phase III study. Efficacy was maintained over the 12 months period, by the investigator assessment, the patient assessment, patient satisfaction and FACE-Q questionnaires.

The proportion of responders at maximum frown, determined by the investigator 1 month after the injection, was maintained over repeated injection cycles (between 82.2% and 87.8%). The corresponding proportions 3 months after injection ranged between 45.3% and 56.8% across the 5 treatment cycles.

Patients (595 in total) receiving Alluzience over a 12 months period were tested for antibody formation. No patients tested positive for toxin-neutralising antibodies.