Cymbalta (Duloxetine HCl) Approved By FDA Advisory Committee For Expanded Pain Indications

The Anesthetic and Life Support Drugs Advisory Committee which advises the FDA on whether to approve new drugs or alter their indications, has voted 8-6 in favor of expanding pain indications for Cymbalta (duloxetine HCl). The Committee's decision is not final - the FDA has to decide - however, the FDA usually goes along with what the Committee recommends.


The Advisory Committee recommended the expanded use of Cymbalta for the treatment of chronic knee and lower back pain.


The Advisory Committee examined efficacy and safety data from three recent Cymbalta studies focusing on chronic (long-term) low back pain, as well as two new studies in chronic pain caused by osteoarthritis of the knee; they also went over the general safety data for the drug.


Eli Lilly, the makers of Cymbalta, wrote in a press release that the submission (of Cymbalta) was supported by currently approved indications in the management of diabetic peripheral neuropathic pain and fibromyalgia.


The Advisory Committee supported - with a split vote - the indication of Cymbalta for chronic low back pain after examining two positive studies. They did not, however, support chronic pain due to osteoarthritis based on a single positive study.


The committee voted that there was not enough evidence to support additional efficacy of 120 mg versus 60 mg in these conditions.


In addition, the committee voted positively regarding the overall safety profile of Cymbalta, including potential liver toxicity, with the majority agreeing that the benefit-risk profile warrants an expanded indication.
Cymbalta
Cymbalta is already approved in the USA for the treatment of (in adults aged over 18 years):

Major depressive disorder
Generalized anxiety disorder
The management of diabetic peripheral neuropathic pain
Fibromyalgia

Cymbalta is not approved for use in pediatric patients.


Some Advisory Panel members were concerned about Cymbalta's potential liver risks, as well as the lack of benefits one of the two studies for osteoarthritis of the knee showed. They said there should be larger and longer lasting trials.


Sources: FDA, Eli Lilly


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