FDAnews Device Daily Bulletin

ALTEA THERAPEUTICS BEGINNING PHASE 1 CLINICAL TRIALS OF NEW TRANSDERMAL PATCH FOR CHRONIC PAIN

May 31, 2006
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Altea Therapeutics announced May 25 it has begun Phase I clinical trials in the U.S. for AT3022, a fentanyl citrate transdermal patch to treat severe chronic pain. The patch uses the firm's PassPort Transdermal System to deliver water-soluble small molecules, proteins, carbohydrates and oligonucleotides across the skin.

AT3022 is designed to provide a safer and more efficacious alternative to current fentanyl patches on the market that can only deliver the highly lipid-soluble base form of fentanyl, Altea said.

The company pointed to a public health advisory issued by the FDA in July 2005 warning of safety issues with conventional patches that use dose titration -- gradually increasing the medication dose to give the body time to adjust -- difficult for patients to manage. Other adverse events associated with traditional fentanyl patches included potential drug abuse from large deposits of the substance left in the skin after patch removal, and potentially life-threatening reactions from leaking or "dose dumping" when heat was applied to the patch, the company said.