CESAMET SUMMARY
CESAMET™ C-II
(nabilone)
Capsules
For Oral Administration
Cesamet™ (nabilone) is a synthetic cannabinoid for oral administration.
Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.
Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).
Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient.
As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increase risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.
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NEWS HIGHLIGHTS
Published Studies Related to Cesamet (Nabilone)
Analgesic and antihyperalgesic effects of nabilone on experimental heat pain. [2008.04]
CONCLUSIONS: Nabilone failed to produce analgesic effects and it did not interact with descending pain inhibitory systems. However, we found that a single 1 mg dose of nabilone reduced temporal summation for women but not men. Although a titration regime and a larger sample of subjects might have provided more robust effects, these preliminary results suggest that nabilone appears effective at relieving hyperalgesic responses in women. Possible neurobiological mechanisms and clinical implications are further discussed.
Nabilone for the treatment of pain in fibromyalgia. [2008.02]
A randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo...
Comparison of analgesic effects and patient tolerability of nabilone and dihydrocodeine for chronic neuropathic pain: randomised, crossover, double blind study. [2008.01.26]
OBJECTIVE: To compare the analgesic efficacy and side effects of the synthetic cannabinoid nabilone with those of the weak opioid dihydrocodeine for chronic neuropathic pain... CONCLUSION: Dihydrocodeine provided better pain relief than the synthetic cannabinoid nabilone and had slightly fewer side effects, although no major adverse events occurred for either drug. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15330757 controlled-trials.com] .
Nabilone for the Treatment of Pain in Fibromyalgia. [2007.10.30]
A randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo...
Low dose treatment with the synthetic cannabinoid Nabilone significantly reduces spasticity-related pain : a double-blind placebo-controlled cross-over trial. [2006.10]
About 30% of patients with chronic upper motor neuron syndrome (UMNS) suffer from disabling spasticity-related pain not sufficiently correctable by conventional treatment. Delta9-tetrahydrocannabinol (Delta(9)-THC) was reported to add benefit in the treatment of pain in patients with multiple sclerosis (MS)...
Clinical Trials Related to Cesamet (Nabilone)
A Phase IV Trial of Cesametâ„¢ Given With Standard Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting [Terminated]
This is a Phase IV, open-label, sequential treatment study in patients who are receiving
standard chemotherapy for non-small cell lung cancer, breast cancer, or colorectal cancer.
(See Section 4. 2.1 for eligible treatment regimens.) The study will take place during the
first 2 cycles of chemotherapy.
Phase 1 of study:
Prior to the first dose of chemotherapy, patients will be instructed on how to complete their
patient diary, which will include a Visual Analogue Scale (VAS) for nausea and a VAS for
pain. In addition, the diary will include a section to list their current pain medications
(see Sample Patient Diary in Appendix I). After being instructed, patients will complete the
VAS for nausea and for pain, as well as listing their current pain medications. Patients will
then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard
serotonin antagonist/corticosteroid regimen.
Beginning on Day 2, the diary will be completed for 5 consecutive days (Days 2-6). Each day,
patients will complete a diary entry pertaining to the preceding 24 hours. The entry will
include the number and time of any emetic episodes, any antiemetic rescue medications used,
VAS for nausea, and side effects of treatment. On the last day of the diary (Day 6), the
entry will include the above daily parameters but will also include a VAS for pain. In
addition, the patient will complete a diary entry pertaining to the 5-day study period that
will include pain medications used. Patients will also complete the Functional Living Index - Cancer (FLIC) questionnaire (see Sample Function Living Index - Cancer questionnaire in
Appendix II).
Patients who either have at least one vomiting episode or at least one report of significant
nausea (VAS > 25 mm) during the first 5-day study period will be eligible for the second
phase of the study.
Phase 2 of the study:
Patients in the second phase will receive a second cycle of the same chemotherapy. The
antiemetic regimen for the second cycle will be the same serotonin antagonist/corticosteroid
regimen as they received in Cycle 1, with the addition of Cesamet.
For Cycle 2 of treatment, patients will receive Cesamet 1 mg the night before chemotherapy is
to be administered. On the day of chemotherapy (Day 1 of Cycle 2), Cesamet 2 mg will be given
1 to 3 hours before the chemotherapy is administered, in addition to the same serotonin
antagonist/corticosteroid regimen as they received in Cycle 1. Patients will receive an
additional dose of Cesamet 2 mg the evening of Day 1.
Patients will receive Cesamet 2 mg BID on Days 2-5. Patients will complete the same 5-day
diary and FLIC questionnaire as they did in Cycle 1. Beneficial effects of Cesamet will be
estimated by comparing the results of the second cycle to the results of the first cycle.
Patients will be evaluated for the first 2 cycles of chemotherapy only.
Evaluation of the Efficacy of Cesametâ„¢ for the Treatment of Pain in Patients With Multiple Sclerosis [Completed]
This study was designed to evaluate the safety and efficacy of Cesametâ„¢ in controlling pain
in subjects experiencing pain due to Multiple Sclerosis.
Evaluation of the Efficacy of Cesametâ„¢ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy [Completed]
This study was designed to evaluate the safety and efficacy of Cesametâ„¢ in controlling pain
in subjects experiencing pain due to diabetic peripheral neuropathy.
Evaluation of the Efficacy of Cesametâ„¢ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy [Completed]
This study was designed to evaluate the safety and efficacy of Cesametâ„¢ in controlling pain
in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with
cancer.
Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis [Recruiting]
The purpose of this study is to determine whether nabilone (Cesamet) when used as an
adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief
over gabapentin alone for the management of neuropathic pain in MS.
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