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ALTEA THERAPEUTICS COMPLETES PHASE II ACUTE PAIN STUDY

August 30, 2005

Altea Therapeutics announced the completion of a multicenter Phase II dose-ranging clinical study in acute pain for its hydromorphone transdermal patch. The hydromorphone patch is in development for the rapid and safe management of moderate-to-severe chronic pain and certain acute pain conditions, and for use by both opioid-tolerant and opioid-non-tolerant patients.

The trial comprised a three-day, randomized, dose-response, pharmacodynamic/pharmacokinetic study in opioid naive patients with acute pain following knee or hip replacement surgery. Fourteen patients wore a new patch every day for up to three successive days. Results demonstrated the minimum dose required to treat postoperative pain in these patients. Patients exhibited steady-state serum hydromorphone levels within four hours, with these levels remaining constant for the three days of the study with no apparent drug accumulation.