FDA expands indication for the use of antidepressant Cymbalta

American pharmaceutical company Eli Lilly has received approval for a new indication of its well known antidepressant Cymbalta

Indication for the use of antidepressant Cymbalta

The drug currenly will be available for use in treatment of chronic musculoskeletal pain, including pain in osteoarthritis, which most commonly occurs in the lumbar region (lumbago). As director of FDA's Center for Drug Evaluation and Research Janet Woodcock indicates, three-quarters of the world's population suffer from chronic pain in a particular period of life. And we sure that it will become not only the alternative way of treatment for such kind of pain, but the most effective.

FDA decision on the expansion of indications for Cymbalta was based on the results of four clinical trials. Patients who took Cymbalta, felt significant pain relief compared with placebo. When members of the Advisory Board of the FDA in August considered a request for extension of Cymbalta indications, they agreed that the drug was effective in treatment of chronic pain for a number patients. But they were opposed to its use in treating arthritis (4 votes against 9), and only 8 out of 13 experts advocated the use of the drug for the treatment of lower back pain.

In spite of this, FDA has implemented changes in the prescription instructions of the drugs.

Now, Lilly can start the actual sales of the drug with enhanced indications for use. Cymbalta is already a best-selling drug for Eli Lilly, with sales of 3,5 billion dollars a year. According to the FDA, 7% of Cymbalta prescriptions, last year, were issued for the treatment of musculo-skeletal pain, including arthritis and pain in the lumbar spine.

At the current time, Lilly is able to provide Cymbalta for millions of people, suffering from arthritis and pain in the lumbar region. The company needs to get the most benefits from the drug sales on the new Cymbalta indications, till the expiration of the drug patent in 2013. Analysts predict a rise in annual sales of the drug by 16% - to $ 500 million, due to current the changes in the prescription manual.