Anesiva Announces Phase II Data on Adlea in Osteoarthritis of the Knee
Anesiva announced preliminary results from a Phase II study showing that a 1-mg treatment with Adlea in patients with moderate-to-severe osteoarthritis of the knee produced reductions in pain that persisted for up to 12 weeks.
Fifty-five patients with osteoarthritis of the knee were randomized to receive either a 1-mg injection of Adlea or three stepped-ascending weekly doses totaling 1 mg of Adlea.
According to the company, in clinical studies, Adlea was well-tolerated and did not cause the side effects often associated with conventional pain medications.
Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. The prolonged analgesic effect resulting from a single or stepped dose does not seem to be associated with the systemic side effects commonly associated with nonsteroidal anti-inflammatory drugs (gastrointestinal and renal toxicities and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity) or opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence and the risk of addiction), the company said.