Recently Published Study Shows Positive Results for ZiNGO in Pediatric Patients

NORTHBROOK, Ill.–(BUSINESS WIRE)–Marathon Pharmaceuticals, LLC, today announced that a recent publication
of a clinical study1 confirmed that ZiNGO® (lidocaine
hydrochloride monohydrate, 0.5 mg) powder intradermal injection system
significantly reduces venous access pain in pediatric patients. The
results were published in the journal Clinical Therapeutics.

ZiNGO® is a fast acting, easy to use, sterile, needle-free product that,
with the push of a button, delivers a 0.5 mg dose of powdered lidocaine
particles into the skin numbing the site in just one to three minutes.
ZiNGO® is currently in use at several major children’s hospitals
nationwide.

The phase III, randomized, double-blind, placebo-controlled study
collected data from 535 patients ages 3-18. Study subjects represented a
broad spectrum of pediatric patients, including those in outpatient as
well as inpatient settings, who were undergoing venipuncture or
peripheral venous cannulation procedures as part of their standard
clinical care. The active system group had significantly (P =
0.0022) less pain compared with the placebo in all age groups combined.

Venous access procedures were performed successfully on the first
attempt in 95.5% of the patients in the active treatment group and 96.2%
in the placebo group, suggesting that ZiNGO did not negatively impact
the ability to access the vein. The most commonly observed adverse
reactions were nausea and vomiting. The incidence of treatment-related
adverse events was similar in both treatment groups: 1.9% in the active
group and 1.5% in the placebo group. No patient experienced a serious
adverse event. There were no reports of vasoconstriction in patients in
either group.

Analgesic efficacy was assessed by patient self-report of venous access
pain (Wong-Baker FACES Pain Rating Scale [3–18 years] and visual analog
scale [VAS; 8–18 years]) and parental observational VAS. Safety measures
included adverse events (AEs) and skin assessments.

“This study confirms that ZiNGO® is an easy-to-administer, fast-acting,
safe and effective, needle-free topical local anesthetic that can be
easily incorporated into the busy health care environment,” said William
T. Zempsky, MD, Professor of Pediatrics and Division Head of Pain and
Palliative Medicine at Connecticut Children’s Medical Center, and an
author of the study.

“Because commonly available local anesthetic products can take up to 30
to 60 minutes to work, making incorporation into the busy healthcare
environment difficult, healthcare providers have had to sacrifice
patient comfort when performing the numerous venous access procedures
that occur each day. ZiNGO® can be a source of needed relief to children
and parents,” Zempsky said.

About Marathon Pharmaceuticals

Marathon Pharmaceuticals, LLC, is a biopharmaceutical company that
develops new treatments for rare diseases with a focus on providing
medicine to patients who currently have no treatment options. The
company is developing a pipeline of treatments for rare neurological and
movement disorders. Marathon is headquartered in Northbrook, Illinois,
with offices in Chicago, New Jersey and Washington D.C. For more
information, visit www.marathonpharma.com.

About Zingo®2

INDICATIONS

ZiNGO® is indicated for use on intact skin to provide topical local
analgesia prior to venipuncture or peripheral intravenous cannulation in
children 3-18 years of age.

ZiNGO® is indicated for use on intact skin to provide topical local
analgesia prior to venipuncture in adults.

Limitation of Use

For external use on intact skin only.

DOSAGE AND ADMINISTRATION

Apply one ZiNGO® to the site planned for venipuncture or intravenous
cannulation, 1-3 minutes prior to needle insertion

Perform the procedure within 10 minutes after ZiNGO® administration

IMPORTANT SAFETY INFORMATION

ZiNGO® is contraindicated in patients with a known history of
sensitivity to local anesthetics of the amide type.

It is not to be used around the eyes or on body orifices, mucous
membranes, or on areas with a compromised skin barrier.

ZiNGO® should only be used on skin locations where an adequate seal can
be maintained.

Patients with severe hepatic disease or pseudocholinesterase deficiency,
because of their inability to metabolize local anesthetics normally, are
at a greater risk of developing toxic plasma concentrations of lidocaine.

Patients with bleeding tendencies or platelet disorders could have a
higher risk of superficial dermal bleeding.

The most common application-site related adverse reactions observed in
clinical studies in adults treated with ZiNGO® were: hypoaesthesia (0%
active treated subjects vs. 0.5% placebo device), burning (0.5%
active-treated subjects vs. 0.4% placebo device) and venipuncture site
hemorrhage (0.4% active-treated subjects vs. 1.7% placebo device).

The most common systemic adverse reaction in adults was dizziness (0.9%
of active-treated subjects vs. 0.7% placebo device).

The most common application-site related adverse reactions observed in
clinical studies in children treated with ZiNGO® were: bruising,
burning, pain, contusion and hemorrhage occurring in 4% of the patients
in each treatment group.

The most common systemic adverse reactions in children were nausea (2%)
and vomiting (1%).

Do not use if the device is dropped or the pouch is damaged or torn.

Click here to: See
Full Prescribing Information
.

REFERENCES:

1Schmitz
ML
, Zempsky
WT
, Meyer
JM
. Safety and Efficacy of a Needle-Free Powder Lidocaine Delivery
System in Pediatric Patients Undergoing Venipuncture or Peripheral
Venous Cannulation: Randomized Double-Blind COMFORT-004 Trial. Clin
Ther.
2015 Jul 8. [Epub ahead of print]

2 Full Prescribing Information. Marathon Pharmaceuticals,
LLC. Northbrook, IL 60062 USA

ZNG-15-025

Contacts

Aileron Communications
Peter Gray, 312.629.9400
pgray@aileroninc.com

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