Summary of Cancellation for Botox Cosmetic

The purpose of this submission was to seek authorization for a new cosmetic indication for the improvement in the appearance of masseter muscle prominence (MMP) in adults.

Currently in Canada, Botox Cosmetic is authorized for the treatment of upper facial rhytids, including forehead, lateral canthal, and glabellar lines. Within the context of this submission, the sponsor proposed to include a new indication for the improvement in the appearance of MMP in adults.

The Botox Cosmetic for MMP clinical development program comprises one pivotal Phase 3 Study 1789-301-008 and 2 supportive studies, Phase 2 Study 191622-130 and Phase 2b Study 1789-202-008. Reliability of the primary efficacy measure, the Masseter Muscle Prominence Scale (MMPS), was evaluated in another Study (191622-128).

Pivotal Phase 3: 1789-301-008

This was a phase 3, double-blind, randomized, placebo-controlled study to compare the safety and efficacy of Botox with placebo in subjects with bilateral MMP. The study evaluated a single Botox administration over a double-blind placebo controlled, single-treatment period and an open label period with up to 2 administrations of investigational product. Intramuscular injections with placebo or Botox in the bilateral masseter muscles were administered for the evaluation of efficacy. Participants were male or female of at least 18 years of age with MMP, as determined to be eligible by the investigator using the MMPS and by the subject using the MMPS-P. Patients with medical conditions such as bruxism or temporomandibular joint disorder were excluded from the study. The primary efficacy endpoint was change in masseter muscle prominence from baseline at Day 90, per investigator assessments of MMP using the MMPS (5 severity grades: 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, 5 = very marked).

At the time of cancellation, the submission review was nearing completion. Health Canada considered some data deficient that would have precluded issuing an approval. The sponsor chose to cancel their submission and potentially re-file at a later date with additional data required by Health Canada.

There is no expected impact for patients using Botox Cosmetic or access to Botox Cosmetic in Canada.