ASTRA EMLA CREAM LAUNCH TO FOLLOW COMPLETION OF 8,000-PATIENT STUDY
ASTRA EMLA CREAM LAUNCH TO FOLLOW COMPLETION OF 8,000-PATIENT STUDY of the topical anesthetic that was approved by FDA on Dec. 30. The open label Children's Hospital EMLA Efficacy Research (CHEER) trial will enroll pediatric patients at 150 hospitals, Astra said. The study "will provide extensive data on EMLA's use in a large number of children's hospitals where invasive dermal procedures are performed," Astra said Dec. 30. The trial will begin in the new year, and Astra expects the commercial launch by the end of the first quarter of 1993. EMLA, a eutectic mixture of the anesthetics lidocaine 2.5% and prilocaine 2.5%, is indicated "as a topical anesthetic for use on normal intact skin for local analgesia" in adults and children older than one month. The cream is applied to patients in an occlusive dressing for up to two hours, after which the skin will remain anesthetized for one to two hours. EMLA cream "has the potential to reduce significantly the fear of needles that is a psychological barrier to so many patients of all ages," Astra declared. Possible procedures where EMLA can be used include venipuncture, central venous port injection, lumbar puncture and bone marrow aspiration. Astra's clinical trials of EMLA compared the drug to subcutaneous lidocaine, intradermal lidocaine, ethyl chloride and placebo, approved labeling notes. EMLA was shown to be superior to placebo in both adults and children, superior to ethyl chloride in adults, comparable to subcutaneous lidocaine and less efficacious than intradermal lidocaine, labeling states. "Most patients found EMLA cream treatment preferable to lidocaine infiltration or ethyl chloride spray," labeling states. "EMLA cream is not recommended for use on mucous membranes because limited studies show much greater absorption of lidocaine and prilocaine than through intact skin," labeling notes. The product also "is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies." In clinical studies involving a total of 1,300 patients, local reactions were seen in 56% of patients, labeling states. These reactions, including paleness (37%), redness (30%), alterations in temperature sensations (7%), edema (6%), itching (2%) and rash (< 1%), "were generally mild and transient, resolving spontaneously within 1 or 2 hours," labeling says. "There were no serious reactions which were ascribed to EMLA cream." EMLA labeling warns against methemoglobinemia, particularly in children under 12 months of age taking medicines that induce methemoglobin (including acetaminophen, benzocaine, nitrates, phenobarbital and phenytoin). EMLA also interacts with Class I antiarrhythmics, labeling states, and so "should be used with caution." Doctors are also cautioned that EMLA may cause severe irritation upon contact with the eye. FDA's approval letter to Astra notes that the firm has agreed to carry out seven postmarketing studies. Astra developed both components of EMLA. The firm markets lidocaine as Xylocaine and prilocaine as Citanest. EMLA is already marketed by Astra in 17 countries worldwide. In 1991 more than 1 mil. pediatric patients used the cream, the company said. Astra filed an NDA (19-941) for the new combination/new formulation on Dec. 27, 1989. Astra will market EMLA in 5 gm and 30 gm tubes.
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