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Please see the end of the video for

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important safety information

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including boxed warning and visit

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XEOMIN.com for full prescribing

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information.

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Hi, I'm Elizabeth Moberg-Wolff,

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and I'm a pediatric physiatrist

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who's been practicing for about 25

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years now.

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I see both children and

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now adults as they get older who

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have spasticity and drooling.

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I was impressed when Merz decided to

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pursue a pediatric indication

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for both sialorrhea and upper limb

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spasticity.

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Xeomin received FDA approval for

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two pediatric indications in

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2020. The first was for

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pediatric spasticity in the upper

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limb for patients ages 2

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to 17, excluding those

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with cerebral palsy.

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The second indication was for

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pediatric chronic sialorrhea for

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patients ages 2 to 17.

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XEOMIN is the first and only

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FDA-approved neuromodulator

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therapy for chronic pediatric

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sialorrhea.

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The sialorrhea in Xeomin

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pediatric study looked at the

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safety and efficacy in 255

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children ages 2 to 17.

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who had intellectual or neurologic

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disabilities and chronic troublesome

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sialorrhea.

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The study was designed as a 16-week

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main period with a 48

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-week open-label extension period.

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All children between two and five

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received Xeomin.

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The children that were older than

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that from six to 17 were

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randomized in a two-to-one ratio

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with those receiving Xeomin

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and the others receiving a placebo.

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In these pediatric patients,

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Xeomin significantly reduced

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the unstimulated salivary

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flow rate.

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Additionally, the pediatric patients

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had sustained reduced

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salivary flow rate through week 16.

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The caregiver's global impression of

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change scores were superior to

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placebo at four weeks and again

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at 16 weeks.

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Patients who were 2 to 5 showed

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the same consistency of change

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and improvement over those weeks.

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In the main period of the study,

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Xeomin demonstrated safety as well

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as efficacy in the children from

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2 to 17 years old.

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No additional safety concerns were

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noted over 64 weeks, and

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there were no additional concerns

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with repeated injections either.

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Xeomin dosing is flexible and

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adjustable depending on the

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patient's weight.

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The recommended dosing for Xeomin is

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based on body weight and it is

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not available for those under 12

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kilograms.

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A second study, the Xara study,

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evaluated the safety and efficacy of

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Xeomin in the upper limb extremities

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for pediatric patients with

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spasticity.

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Pediatric patients ages 2 to

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17 with either one or both

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arm upper extremity spasticity

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were randomized into groups of

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either 2, 6, or 8

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units per kilogram of Xeomin.

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In pediatric patients with upper

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limb spasticity, improvements were

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seen in both the Ashworth scale.

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as well as the global impression of

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change scale.

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86% of the patients who

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were treated with the eight units

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per kilogram of Xeomin had

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a change of one or greater in their

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Ashworth score.

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71% of the patients who had

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two units per kilogram.

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In this study, Xeomin demonstrated

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safety in patients with upper limb

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spasticity.

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Rates of adverse reactions did not

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increase with higher doses.

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Xeomin has flexible weight

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-based dosing that is adjustable

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to the patient's spasticity needs.

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Xeomin is the only FDA approved

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neuromodulator with pediatric

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indicated dosing guidelines

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for five clinical upper

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extremity spasticity patterns.

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Out of the nearly 2,650

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patients, only nine

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adult patients and four pediatric

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patients developed neutralizing

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antibodies and none developed

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clinical resistance.

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All of these patients had had

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injections of Dysport or Botox

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previously.

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So if clinicians or patients have

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questions, they can go to Merz

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Connect where they have a lot of

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information about the product, the

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savings program, and support.

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As a clinician, I've been extremely

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pleased with Xeomin.

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Thanks for listening, and I hope you

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learned something today.

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Have a great day.