ZingoTreatment for Local Anesthesia
Update: Zingo Now FDA Approved - August 16, 2007
Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children
SOUTH SAN FRANCISCO, Calif., November 27, 2006 -- Anesiva, Inc. announced today that the company has filed a New Drug Application (NDA) with the FDA for marketing clearance of Zingo to treat the pain associated with venous access procedures in children. As part of the company's continued development of Zingo, Anesiva expects to begin a follow-on clinical trial in adults in early 2007. As previously announced, Anesiva has obtained commitments to purchase approximately $45 million of its common stock, which it anticipates closing on November 28, 2006.
The company filed the NDA using the Common Technical Document (CTD) format, which can be reviewed by both the U.S. FDA and international regulatory authorities for domestic and international registration of new therapeutics.
Data from two pivotal Phase 3 clinical studies that serve as the foundation of the NDA demonstrated that Zingo (previously known as 3268), a fast-acting, local anesthetic, provided statistically significant pain relief in children undergoing venous access procedures, such as intravenous (IV) line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. In addition to the positive efficacy data from the two trials, treatment with Zingo was found to be safe and well tolerated. The two studies collectively enrolled 1,109 patients at 15 clinical centers in the United States.
Zingo Mechanism of Action and Market Potential
Zingo is a needle-free system that delivers lidocaine powder into the epidermis of the skin and provides analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options.
In hospitals in the United States, approximately 400 million venous access procedures occur each year. In pediatric patients alone, there are 18 million annual procedures. In addition to the hospital population, opportunities exist for Zingo in hemodialysis and blood donation centers, as well as physicians' offices and clinical laboratories.
Posted: November 2006
- Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults - January 9, 2009
- Anesiva Receives FDA Approval for Zingo, a New, Innovative Productto Reduce Pain Associated with Needle Insertion Procedures inChildren - August 17, 2007
- Endo Comments on Notices Received From Anesiva Regarding Zingo - April 10, 2007
- Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007