With the U.S. approval Friday of Anesiva's lidocaine product Zingo, hospitalized children will have something less to fear: needle sticks from i.v. insertions and blood draws.
The product is approved for use in patients ages 3-18 years. Anesiva, based in South San Francisco, is testing Zingo in adult use and plans to soon seek approval for that population, Chief Executive Officer John P. McLaughlin told BioWorld Today.
About 400 million venous access procedures occur in U.S. hospitals each year, he noted, adding that 18 million of those are in pediatric patients.
The product's unique delivery system, a needle-free, disposable intradermal injection system that delivers 0.5 milligrams of powdered sterile lidocaine into the skin via compressed helium, is a "major leap forward for pain management," said William T. Zempsky, associate professor of pediatrics at the University of Connecticut and associate director of the Pain Relief Program at Connecticut Children's Medical Center in Hartford.
Zempsky, who led the pediatric clinical trials of Zingo, noted that the product's rapid onset of action allows for intravenous line placement or venipuncture to begin 1-3 minutes after administration. Most other topical anesthetics can take up to 30 minutes to numb the skin, he told BioWorld Today.
The drug was tested in more than 1,400 children, Zempsky said. Results of two double-blind, placebo-controlled Phase III clinical studies showed a "statistical significance" that use of Zingo reduced pain compared with placebo.
Adverse events reported were mild, he said, and included redness at the administration site.
Needle sticks are a great source of anxiety for children, Zempsky said, adding that Zingo will make a child's medical experience less fearful.
Health care practitioners also will appreciate the product because it allows for uninterrupted care of the patient because of its rapid action, he said.
Kathleen Cowling, an attending emergency medicine physician at Covenant HealthCare in Saginaw, Mich., called the product "awesome," adding that she and her colleagues are eagerly awaiting the availability of Zingo in hospitals.
"It will be nice to know that we have something that can work fast," she said.
Cowling noted that the pre-filled device, which carries a relatively low dose of lidocaine, also will help ensure that there is less chance of a patient receiving a toxic dose of the topical drug.
The FDA issued a public health advisory in February warning about the potential hazards of topical anesthetic gels, creams, and ointments intended to numb the skin.
Anesiva plans to target hospitals as its main customer for Zingo, McLaughlin said, adding that the firm will be working hard to get the drug on all U.S. hospital formularies. Outpatient surgery centers, he said, are another setting where the drug could be used.
McLaughlin did not disclose details of Anesiva's marketing plan, but noted that the firm plans to announce the launch date of the product at a meeting in New York next month.
Anesiva is also developing Adlea (formerly 4975), an agonist of transient receptor potential vanilloid 1.
The injectable drug is being studied in patients with osteoarthritis of the knee. Preliminary results of a Phase II trial showed that administration of 1 mg of the drug substantially reduced pain in patients for up to 12 weeks.
On word of Zingo's approval, Anesiva's shares (NASDAQ:ANSV) rose as high as $7 from Thursday's close of $5.19, but later dropped to close at $5.52 Friday.