Zingo
Rapid, topical, local analgesic
Zingo™ provides topical, local analgesia to reduce the pain associated with peripheral IV
insertions or blood draws, in children three to 18 years of age. Zingo is an easy-to-administer,
single-use, needle-free system containing 0.5 mg sterile lidocaine powder. It provides a rapid
onset of action, allowing intravenous line placement or venipuncture to begin one to three
minutes after administration.
In two pivotal, randomized, double-blind, placebo-controlled, Phase 3 clinical studies, 1,114
patients across 15 U.S. clinical centers received treatment with Zingo or placebo one to three
minutes before blood draws or IV line placements at the back of hand or antecubital fossa (crux
of the elbow): Zingo demonstrated a statistically significant reduction in procedural pain
compared to placebo in children three to 18 years of age. The most common adverse reactions
were redness (erythema), red dots (petechiae) and swelling (edema) at the site of
administration.
In August 2007, the U.S. Food and Drug Administration (FDA) approved Zingo to reduce the
pain associated with peripheral IV insertions or blood draws in children three to 18 years of
age.
Initial results of a large randomized, double-blind, placebo-controlled Phase 3 clinical trial,
enrolling nearly 700 adult patients, demonstrated that patients undergoing venipuncture or
peripheral IV cannulation one to three minutes after treatment with Zingo experienced
significantly less pain versus placebo. The incidence of adverse events was no higher in active
drug group vs. patients who received placebo. Anesiva expects to file a supplemental new drug
application (sNDA) with the FDA to expand Zingo’s label indication to include adults in the first
quarter of 2008.
Anesiva plans to market Zingo with a targeted pediatric hospital-based specialty sales force.
Zingo will be co-promoted with and distributed by Sagent Pharmaceuticals, Inc.
Among Zingo’s properties:
Zingo Mechanism of Action
Zingo delivers a powder form of lidocaine. Instead of using a needle to deliver the analgesic,
Zingo uses compressed gas to accelerate the lidocaine particles into the skin. This provides
analgesia in one to three minutes.
Guidelines and recommendations from the American Academy of Pediatrics, the American
Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to
venous access procedures.
References:
Zingo™ provides topical, local analgesia to reduce the pain associated with peripheral IV
insertions or blood draws, in children three to 18 years of age. Zingo is an easy-to-administer,
single-use, needle-free system containing 0.5 mg sterile lidocaine powder. It provides a rapid
onset of action, allowing intravenous line placement or venipuncture to begin one to three
minutes after administration.
In two pivotal, randomized, double-blind, placebo-controlled, Phase 3 clinical studies, 1,114
patients across 15 U.S. clinical centers received treatment with Zingo or placebo one to three
minutes before blood draws or IV line placements at the back of hand or antecubital fossa (crux
of the elbow): Zingo demonstrated a statistically significant reduction in procedural pain
compared to placebo in children three to 18 years of age. The most common adverse reactions
were redness (erythema), red dots (petechiae) and swelling (edema) at the site of
administration.
In August 2007, the U.S. Food and Drug Administration (FDA) approved Zingo to reduce the
pain associated with peripheral IV insertions or blood draws in children three to 18 years of
age.
Initial results of a large randomized, double-blind, placebo-controlled Phase 3 clinical trial,
enrolling nearly 700 adult patients, demonstrated that patients undergoing venipuncture or
peripheral IV cannulation one to three minutes after treatment with Zingo experienced
significantly less pain versus placebo. The incidence of adverse events was no higher in active
drug group vs. patients who received placebo. Anesiva expects to file a supplemental new drug
application (sNDA) with the FDA to expand Zingo’s label indication to include adults in the first
quarter of 2008.
Anesiva plans to market Zingo with a targeted pediatric hospital-based specialty sales force.
Zingo will be co-promoted with and distributed by Sagent Pharmaceuticals, Inc.
Among Zingo’s properties:
- Rapid onset of analgesia in 1-3 minutes after administration
- Incorporate Zingo into the peripheral IV procedure 1-3 minutes prior to needle insertion
- Simple to use, easy to administer
- Needle-free
- In clinical trials, the most common adverse reactions (>5%) were skin reactions at the
site of administration: redness (erythema), red dots (petechiae) and swelling (edema)
Zingo Mechanism of Action
Zingo delivers a powder form of lidocaine. Instead of using a needle to deliver the analgesic,
Zingo uses compressed gas to accelerate the lidocaine particles into the skin. This provides
analgesia in one to three minutes.
Guidelines and recommendations from the American Academy of Pediatrics, the American
Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to
venous access procedures.
References:
- Zingo full prescribing information. Anesiva, Inc. 2007.
- Zempsky WT, Bean-Lijewski J, Kauffman RE, Koh JL, Malviya SV, Rose JB, Richards PT, Gennevois
DJ. Needlefree powder lidocaine delivery system provides rapid and effective analgesia for
venipuncture or cannulation pain in children: the randomized double-blind COMFORT-003 trial.
Pediatrics. In press. - LHM Device User Study Report. Anesiva, Inc. October 2007.
- American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health,
American Pain Society Task Force on Pain in Infants, Children, and Adolescents. The assessment
and management of acute pain in infants, children, and adolescents. Pediatrics. 2001;108:793-797. - Infusion Nurses Society, Journal of Infusion Nursing, 2006;29 (suppl 1):S1-S92
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