surged Wednesday thanks to favorable clinical trial results for milnacipran, their experimental drug for treating fibromyalgia syndrome.
Preliminary results of a late-stage clinical trial, released after the market closed Tuesday, showed that the drug met the study's goals of measuring pain relief. A more detailed review of the clinical trial involving nearly 1,200 people will be completed in the coming weeks, the companies said.
Patients with the fibromyalgia syndrome experience chronic pain and stiffness throughout their bodies and also can suffer from fatigue and insomnia.
If the full review confirms the preliminary results, the companies plan to seek approval from the Food and Drug Administration by year-end.
The development had shares of tiny Cypress soaring by $8.61, or 102%, to $17.06. Milnacipran is the company's closest-to-market compound. Cypress licensed the drug from France's
Pierre Fabre Medicament
Forest, which signed a marketing agreement with Cypress in 2004, rose $2.71, or 5.2%, to $54.59. Forest has cited milnacipran as one of several key compounds for its future growth, especially when patents expire on top-selling drugs early in the next decade. The antidepressant Lexapro and the Alzheimer's disease drug Namenda now account for 61% and 19% of corporate revenue, respectively.
Milnacipran has had a complicated history in the U.S. In September 2005, the companies said a late-stage clinical trial had failed to meet its goals, but they said they would continue developing the drug and conducting additional tests.
In the latest clinical trial, patients received one of two dosage strengths of milnacipran or a placebo. In measurements of pain, the study found that both 100 milligram and 200 milligram doses achieved statistically significant benefits compared with the placebo.
There were high drop-out rates for each group -- 35% for the high dose, 34% for the low dose and 28% for the placebo. The most common side effects that caused milnacipran patients to quit the test were nausea, palpitations, depression and headaches. Each side effect occurred in less than 5% of patients.
Forest and Cypress say milnacipran is sold in 32 foreign markets as a treatment for depression and has been available for seven years.