Needle pain device OKd for children / Anesiva’s new treatment puts puff of drug on skin
Shares in the South San Francisco biopharmaceutical company Anesiva Inc. rose more than 6 percent Friday after it said U.S. drug regulators had approved its treatment to prevent pain in children about to undergo procedures such as drawing blood or inserting intravenous lines.
The product, Zingo, delivers a measured dose of the painkiller lidocaine into the skin without the use of a needle. The drug, in powdered form, is propelled into the outer skin layer by a puff of helium gas from a disposable device that looks something like a giant marker pen.
The lidocaine powder dissolves in the skin, anesthetizing the site within minutes, the company said. Zingo will compete with products that take 20 minutes or more to numb the skin, said Anesiva chief executive John McLaughlin. The lag time can be a practical problem for busy doctors and nurses who must wait for the drug to take effect before drawing blood or inserting an IV line, he said. Often they forgo the use of a painkiller, McLaughlin said.
Dr. Russell Reiff, a pediatrician at Kaiser Permanente in San Francisco, said pain control should always be considered in the treatment of children. Reiff said Anesiva may have provided a useful option for doctors. But he said the product will be weighed against other alternatives. And the circumstances when Zingo might be used could be limited.
Doctors are most likely to use painkillers for children with serious conditions who need repeated blood tests and other procedures that tap into veins. Often a parent can apply a painkiller such as EMLA, a lidocaine-containing cream, an hour or so before a scheduled procedure so that practitioners need not wait for it to take effect, he said.
For some children, the addition of another step such as a Zingo treatment might prolong the fear and anxiety associated with needles. And doctors will want to be sure the pressure injection itself isn’t painful, Reiff said.
Patients will hear a sound like a balloon popping when Zingo delivers the medicine, a package insert for the drug advises. The most common side effects of Zingo were redness, red dots on the skin and swelling, Anesiva reported. “It’s painless,” said McLaughlin. “You feel a puff of air.”
The Food and Drug Administration approved Zingo for use in children ages 3 to 18. Anesiva is finishing a trial in adults and expects to seek FDA approval in that population. The company estimates that a total of 400 million procedures accessing veins take place in the United States every year, and more than 18 million are performed on children. McLaughlin said revenues from Zingo could reach $150 million to $200 million a year. But the company has not said when it expects sales to peak. In a research note, Lazard Capital Markets analyst Megan Murphy estimated sales of $67 million by 2013. Anesiva is a banking client of Lazard.
Zingo is the first approved product for Anesiva, which was formed in 2005 through the merger of Corgentech of South San Francisco and the private New Jersey company AlgoRx Pharmaceuticals. Corgentech, which had suffered the failure of its lead drug candidate, devoted its resources to the development of AlgoRx’s experimental pain medications.
Shares in Anesiva gained 33 cents or 6.36 percent Friday to close at $5.52.
E-mail Bernadette Tansey at btansey@sfchronicle.com.
