Recently, Eli Lilly’s (LLY) Cymbalta received approval from the US Food and Drug Administration (FDA) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. This approval is the sixth one for the drug, which is also approved for the acute and maintenance treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and fibromyalgia and for the acute treatment of generalized anxiety disorder, all in adults.
The FDA approval is based on encouraging data from a double-blind, placebo-controlled trial carried out with GAD patients who had initially responded to treatment with Cymbalta (60-120 mg/day) during a 26-week study. Following a random selection of these patients, 216 of them received the drug while 213 were on placebo.
At the end of the trial, it was observed that the time for relapse of GAD was longer for patients taking Cymbalta compared to patients taking placebo. While the estimated probability of relapse at 26 weeks of maintenance treatment was 46.4% for placebo, it was 15% for Cymbalta. However, the study was not without any side effects – such as nausea, headache, dry mouth, diarrhea, dizziness, constipation, fatigue and increased sweating.
Generalized anxiety disorder is a chronic illness which affects nearly 7 million Americans at any given time. Symptoms of the disease include excessive worry or anxiety over a certain period (six months or longer), difficulties controlling worry, irritability, poor concentration, sleep disturbances, fatigue, restlessness and muscle tension. The state of the patient may worsen if left untreated.
Cymbalta is one of the key products in Lilly’s portfolio. During the third quarter of 2009, it recorded sales of $790 million, up 10% compared to the year ago period. We expect the approval for additional indications will boost its sales further.
Read the full analyst report on “LLY”
Zacks Investment Research
