WILMINGTON, Del--Zeneca Inc. has received FDA clearance to market
Kadian (morphine sulfate sustained release) capsules, a new single
daily dose sustained-release (SR) morphine formulation, for the
management of moderate to severe chronic pain when treatment with
an opioid analgesic is indicated for more than a few days.
Kadian is the first oral SR morphine in the US that offers the
option of 24-hour pain control with a single dose, the company
said.
The largest controlled clinical study of Kadian was conducted
in cancer patients with moderate to severe chronic pain at 28
US centers.
After stabilization with an immediate-release morphine solution,
152 patients were randomized to receive one of three treatments:
Kadian once every 24 hours, Kadian every 12 hours, or MS Contin
(morphine sulfate controlled-release) every 12 hours.
Kadian once every 24 hours was shown to be as effective as the
other two regimens, and there were no significant differences
in side effects.