Topical Analgesia Product for Children Approved
Anesiva, Incorporated received FDA approval for their powder intradermal injection system, Zingo. The needle-free system provides children with local analgesia and is indicated for children between the ages three to 18.
The system delivers microcrystals of lidocaine to the epidermis. The contained delivery system uses compressed gas to facilitate delivery of treatment directly into the epidermis with rapid uptake. The microcrystals dissolve rapidly, delivering the analgesic effect.
The effect of therapy is noted within one to three minutes of treatment delivery. The fast action of the drug is appealing in the practice of care, particularly busy emergency rooms. This prevents breaks in care delivery to address analgesic concerns.
Pain associated with venipuncture and other venous access procedures, such as placement of intravenous lines, is a commonly cited cause of discomfort among children being hospitalized. Recommendations from the American Academy of Pediatrics, the Infusion Nurses Society, and the American Pain Society include use of topical analgesia before venipuncture activities.
Regular compliance of this practice has been limited due to the extended time period required to deliver appropriate analgesia. Anesiva’s new product overcomes this limitation seen with current approaches. An additional Phase III study is ongoing to collect continued data on the safety and efficacy of Zingo in adult populations. Other ongoing investigation is evaluating delivery of other therapeutic agencies with the same needleless delivery system.
August 20, 2007 Related topics: Product Launches, New Technology & Innovation, Trends, Pediatrics, Anesthesiology