US FDA approves first neurotoxin for chronic sialorrhea

Allergan’s Botox is the most familiar name to many when it comes to neurotoxins and its use as a cosmetic treatment; however, neurotoxins are now beginning to carve out further indications in a range of therapeutics areas.

Merz has now developed four approvals for its Xeomin treatment, including in its use for the treatment of upper limb spasticity, in patients with cervical dystonia and to treat abnormal spasm of the eyelids.

There are more than 600,000 adults suffering from chronic sialorrhea, according to a statement​ released by Kevin O’Brien, head of neurosciences for Merz North America. The condition, also known as excessive drooling, is a common symptom for those suffering from neurological disorders, such as Parkinson’s disease or cerebral palsy.

Sub-heading: Crowded market

Allergan’s Botox has also developed indications for use in chronic migraines, further increasing sales to reach $3.2bn (€2.73bn). As a result, more companies are now trying to develop their own alternatives to the neurotoxin.

Evolus, for example, had developed its product, DWP-450, and applied for a biologics license application (BLA) to the US Food and Drug Administration (FDA) – only for its CMO to receive a complete response letter that blocked its application​.