SAN FRANCISCOA new morphine formulation that combines
immediate-release and extended-release beads offers a once-daily alternative to
the controlled-release morphine formulation MS Contin (MSC). A study compared
the new product, once-daily Morphelan (morphine sulfate, rapid onset extended
relief [MROER]), a convenient and effective option for pain management, with
Mary Simmonds, MD, and colleagues presented a subgroup analysis
of the 39 cancer patients included among 272 subjects randomized to either MSC
(n=11) or one of three doses of MROER. The subgroup included 11 patients with
lung cancer, 9 with breast cancer, 4 with pancreatic cancer, and 15 with other
The MSC dose was set after a 7 to 21 day stabilization period,
during which patients reached a favorable balance between adverse effects and
analgesia, requiring four or fewer rescue doses of oxycodone (Percolone,
Roxicodone) per day. The MROER doses were set at 50% (n = 11), 100% (n = 7), or
135% (n = 10) of the MSC stabilization dose. (Oxydocone rescue doses were 10% of
the total daily dose of morphine).
The study enrolled adult patients with moderate-to-severe pain,
requiring treatment with 60 to 1,000 mg of oral morphine equivalents per day.
Dr. Simmonds said that the stabilization period was followed by a 7-day, double
blind, double dummy, parallel-design period to evaluate the safety and efficacy
of the new morphine formulation. It can also be given mixed in applesauce for
patients who have difficulty swallowing.
The primary efficacy variables were pain intensity, as measured
by change from baseline on the Visual Analog Scale (0=no pain, 100=excruciating
pain). Pain intensity was also measured by change from baseline on the Pain
Descriptor Scale (0=no pain, 227=excruciating pain). The third primary efficacy
variable was change from baseline in the total amount of rescue medication
Effects on the primary efficacy variables were comparable for
once daily MROER at 100% of the stabilization dose of twice daily MSC. (See
Figure 1.) Side effects were comparable and were those generally associated
with opioids such as headache, nausea, somnolence, and constipation.
"Once-daily MROER and twice daily MSC were clinically
comparable in pain control in cancer patients," Dr. Simmonds said.
"The once-daily, rapid onset extended-release formulation offers a
convenient and effective option for pain management in these patients."