New FDA Drug Approval

[Doc R]

The Fibromyalgia Research Blog
FDA Approves Cymbalta for Fibromyalgia
Posted: 17 Jun 2008 03:29 PM CDT
The FDA approved duloxetine (Cymbalta) as a medication for
fibromyalgia earlier this week. Cymbalta is a serotonin-norepinphrine
reuptake inhibitor. It is also used for anxiety, major depression and
peripheral diabetic neuropathy. It has been shown to be effective for
some fibromyalgia patients. Cymbalta, made by Lilly, is the second
drug to ever be approved for fibromyalgia. Last year Lyrica
(pregabalin), an anti-convulsant, became the first fibromyalgia drug
approved by the FDA.

The added indication [for fibromyalgia] was approval on the basis of
data from two three-month clinical trials of 874 fibromyalgia
patients. In both studies, compared with placebo, duloxetine was
associated with more than a 30% reduction in pain as measured by the
Brief Pain Inventory (BPI) 24-hour average pain scale.

Moreover, patients randomized to duloxetine reported significant pain
relief during the first week of treatment.

In both studies the majority of duloxetine patients -- 65% in one
study and 66% in the other -- said they felt better since beginning
treatment with 60 mg of duloxetine daily, as measured by a self-
assessment (Patient Global Impression of Improvement).

Cymbalta's side effects include nausea, dry mouth, constipation,
decreased appetite, sleepiness, increased sweating, and agitation.
Twenty percent of duloxetine patients discontinued the study drug
because of side effects.


NOTE: All chiropractic cranial practitioners have noticed marked
changes in Autonomic Nervous System balance. This includes how the
body uses neurotransmitters such as Serotonin. Side effects tend to be
better health!