FDA approves neurotoxin product Xeomin for treatment of chronic salivation in adult patients

salivation is mainly manifested in drooling, a common symptom in patients with neurological disorders, including Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS), cerebral palsy (CD), and strokerecently, MerzIncannounced that the
FDAhas approved neurotoxinproduct(incobotulinumtoxinA), a type A compound free botox toxin, for the treatment of chronic (long-term) salivation in adult patientsXeominXeomin is a prescription drug that works by injecting it into the muscles or glandsIn the U.Smarket, Xeomin was first approved in 2010 for treatment of adult dystonia, eyelid spasms (eyelid spasms that have previously been treated with El-Kebao-botox (onabotulinumtoxinA, type A botulinumtoxin), and then in 2015 for treatment of adult upper limb spasmsthe studyXeomin was based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical studyThe study enrolled 184 adult patients with salivary, 36 with placebo treatment, 74 patients with 75 units of Xeomin and 74 patients treated with 100 units of Xeomindata show that the study successfully reached a common primary endpoint: in the fourth week of treatment, the 100 units of Xeomin injection group showed a statistically significant improvement in both the non-stimulating saliva flow rate (uSFR) and the overall change impression scale (GICS) relative to the pre-injection baseline (p-0.004, p-0.002, respectively) GICS is a scoring system commonly used by clinicians to evaluate the treatment of neurological disorders the overall incidence of adverse events in the study, the placebo group was similar to the treatment group, with no new or unanticipated adverse events