Today Eli Lilly and Co. announced the FDA approval of Cymbalta (duloxetine HCI) for the management of fibromyalgia. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. This makes Cymbalta the second medication ever to be approved for fibromyalgia, following Lyrica’s approval in June 2007.
This is exciting news for fibromyalgia patients. No single medication or treatment is right for everyone, so the more options we have, the better our chances of finding something that will help us. And the more approved medications that are available, the more comfortable doctors will become in attempting to treat fibromyalgia. Also, Lyrica and Cymbalta are different types of medications, which hopefully will mean more patients will find relief from one of them.
In Lilly’s press release, Madelaine Wohlreich, M.D., medical advisor and research physician at Lilly, said, "The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve functioning in this difficult-to-treat disorder."
Lilly established the efficacy of Cymbalta in two pivotal three-month clinical trials involving 874 patients with fibromyalgia. In both studies, Cymbalta reduced pain at study endpoint compared with placebo as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale. The BPI is a scale that measures the severity of pain.
Significant improvement in pain for Cymbalta vs. placebo was observed in the first week of each study. Fifty-one percent and 55 percent of patients on Cymbalta had a 30 percent improvement on the BPI at endpoint (clinically meaningful relief is considered at least 30 percent pain reduction).
In addition, 65 percent and 66 percent of patients taking Cymbalta 60 mg daily reported feeling better at endpoint as measured by the Patient Global Impression of Improvement (PGI-I). The PGI-I is a patient-rated scale that evaluates how much improvement has occurred since beginning treatment.
Cymbalta 60 mg was superior to placebo on the Fibromyalgia Impact Questionnaire (FIQ) Total Score. The FIQ is a scale that is used to assess and evaluate the impact of fibromyalgia on aspects of health and functioning believed to be most affected by the disorder.
In four pooled studies, the most commonly observed adverse events in Cymbalta-treated patients with fibromyalgia (greater than or equal to 5 percent and at least twice placebo) were nausea (29 percent), dry mouth (18 percent), constipation (15 percent), decreased appetite (11 percent), sleepiness (11 percent), increased sweating (7 percent) and agitation (6 percent). In the placebo-controlled clinical trials, the overall discontinuation rates due to adverse events for Cymbalta vs. placebo were 20 percent and 12 percent, respectively.
Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, and the management of fibromyalgia and diabetic peripheral neuropathic pain in adults age 18 years and older. Cymbalta is not approved for use in pediatric patients.
Safety Information and Precautions
Cymbalta is not for everyone. You should not take Cymbalta if you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled glaucoma. You should speak with your doctor about any medical conditions you may have including kidney problems, glaucoma, diabetes, or liver problems.
You should also talk to your doctor about alcohol consumption and all medications you are taking, including those for migraine, to avoid a potentially life-threatening condition. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. You should consult with your doctor before stopping Cymbalta or changing the dose and if you are pregnant or nursing.
For full prescribing information see www.cymbalta.com
Published On: June 16, 2008