Chain Drug Review - FDA grants approval to Eli Lilly’s Strattera
INDIANAPOLIS — Eli Lilly and Co. has received Food and Drug Administration clearance for Strattera (atomoxetine HCl) for maintenance treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved nonstimulant to treat ADHD in children, adolescents and adults.
“The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD,” says Thomas Spencer, associate professor of psychiatry at Harvard Medical School. “This is critical, as ADHD may be a lifelong disease, and effective long-term control of symptoms may mean improved outcomes in children and adolescents.”
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The safety and efficacy of Strattera in the maintenance of ADHD were demonstrated in what Lilly describes as one of the largest relapse-prevention studies ever conducted on ADHD, which is among the most common mental health disorders in children and adolescents. The 18-month trial of about 600 children and adolescents from age 6 to to age 15 who met specified criteria for ADHD showed that Strattera was superior to a placebo in maintaining continuous efficacy in patients.
In addition, at the end of the trial patients taking Strattera had lower relapse rates (2.5%, compared with 12.2% for patients taking the placebo).
The drug is said to provide relief from ADHD symptoms throughout the day and into the evening.
Separately, Lilly has submitted a supplemental new drug application to the FDA seeking approval for a new indication for Cymbalta (duloxetine HC1) for the management of chronic pain. The submission is based on outcomes of clinical trials of patients with chronic osteoarthritis pain of the knee and chronic lower-back pain, in addition to data from previously completed studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia.
Cymbalta was studied for chronic pain of at least moderate severity in adults who required daily treatment for an extended period.
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