抄録
A multicenter study was conducted to evaluate the efficacy and safety of AN-982, a unit-dose oral solution of morphine hydrochloride with a less bitter taste and improved stability at room temperature.
Methods: AN-982 was administered to the following three types of patients:
1) Patients who were strong opioid naive and whose pain control was insufficient with non-opioid analgesics or weak opioids were started on an initial dose of 5 – 10 mg of AN-982 every 4 hours and the dose was titrated to achieve adequate analgesia (new subjects).
2) Patients being treated with other immediate-release oral morphine formulations were switched to AN-982 using the same dose and dosing interval as those of the other immediate-release oral morphine (switched subjects).
3) Patients being treated with Controlled Release Morphine Sulfate tablets who had “breakthrough” pain were administered AN-982 as the rescue medication (rescued subjects).
Results:
1) The efficacy rate in new subjects, switched subjects, and rescued subjects was 97.0% (32/33), 100% (9/9), and 77.5% (31/40), respectively.
2) Adequate pain relief was achieved on the first day of administration in 55.6% (15/27) of the new subjects, and the average time required to achieve adequate pain relief was 2.1 days.
3) In the switched subjects, adequate pain relief was achieved by administration of AN-982 at the same dose and dosing interval as those of the previous immediate-release oral morphine formulations.
4) In the rescued subjects, significant improvement of the pain and VAS scores were observed from 15 minutes after the administration of AN-982 and continued for 2 hours.
5) The overall incidence of adverse reactions was 74.1% (63/85) after AN-982 administration, and the incidence was similar to that observed with controlled-release morphine tablets during development. The most frequent adverse reactions were constipation, nausea, vomiting, and drowsiness, which are all well-known side effects of morphine.
Conclusion: AN-982, a rapidly-acting oral solution of morphine hydrochloride, is not only effective and useful for pain management in cancer patients (as a regular analgesic and as rescue medication), but also assists medical personnel in preparing morphine formulations.
