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.
“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”
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 ef?cacy 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
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