Regulatory Decision Summary for Xeomin

Xeomin contains a muscle relaxant, botulinum neurotoxin type A (BoNT/A), produced by the bacterium Clostridium botulinum. Botulinum neurotoxin type A (BoNT/A) blocks signal transmission at nerve ending, resulting in relaxation of related muscles. Xeomin has been approved for marketing in Canada for the treatment of blepharospasm, cervical dystonia, stroke-associated upper limb spasticity and chronic sialorrhea associated with neurological disorders in adult subjects. The purpose of this Supplemental New Drug Submission (SNDS) was to seek market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for proposed updates to the Xeomin Product Monograph (PM) to modify the currently authorized upper limb spasticity (UL SP) indication to include adult patients with upper limb spasticity (UL SP) regardless of the etiology; to include treatment of spastic shoulder muscles in the upper limb spasticity (UL SP) indication; and to change the initial dosing per muscle in the treatment of upper limb spasticity (UL SP) from a fixed dose to a flexible dose.

Spasticity (SP) is a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which might interfere with movement, speech, or be associated with discomfort or pain. Spasticity is usually caused by damage to nerve cells within the brain or spinal cord that control muscle movement. For treatment of spasticity (SP), locally injected botulinum neurotoxin type A (BoNT/A) relaxes muscles and alleviate the effects of spasticity (SP) by blocking the signal transmission from a never ending to the related muscles.

The previously authorized upper limb spasticity (UL SP) indication for Xeomin was restricted to patients with stoke-associated upper limb spasticity (UL SP). In this submission, the sponsor proposed to include patients with upper limb spasticity (UL SP) regardless of the cause for the nerve damage. This proposed change is considered acceptable primarily based on the collective evidence from three submitted clinical trials.

The sponsor’s proposed inclusion of treatment of spastic shoulder muscles in the upper limb spasticity (UL SP) indication is considered unacceptable due to lack of supporting evidence.

The sponsor’s proposed modification of the initial dosing per muscle from a fixed dose to a flexible dose with the total dose per treatment session at 400 U in treatment of upper limb spasticity (UL SP) in adults is considered acceptable primarily based on the evidence from a clinical trial.

The results of the studies in this supplemental new drug submission (SNDS) do not alter current understanding of the efficacy and safety of the product in treatment of upper limb spasticity (UL SP) in adults. Therefore, the benefit/risk ratio of Xeomin in treatment of upper limb spasticity (UL SP) in adults remains favorable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

A Notice of Compliance was recommended.

For further details about Xeomin, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.