Alkermes depression drug fails in studies, shares plunge
(Reuters) – Alkermes Plc said its drug for major depressive disorder did not meet the main goal of improving depression symptoms in two late-stage studies, sending its shares down 32 percent in premarket trading.
The first study, comprising 385 patients, tested 2 mg and 0.5 mg doses of the drug. Although the main goal of the study was not met, the 2 mg dose of the drug was found to be effective compared with a placebo, Alkermes said.
In the second study with 429 patients, however, placebo response was greater and no treatment effect was observed, the company said.
“Clinical trials of new medicines for the treatment of major depressive disorder are complicated by significant placebo response,†Elliot Ehrich, Alkermes’ chief medical officer, said.
The studies tested patients with an inadequate response to standard therapies for clinical depression.
All hopes are now on Alkermes’ third ongoing late-stage study. The company said based on data from the first two trials, patient enrollment for the third study will be increased.
An estimated 17 million people in the United States suffer from major depressive disorder every year.
Alkermes’ studies were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), which is commonly used to measure the severity of depressive episodes in patients.
The company’s shares were at $41.00 before the bell on Thursday after closing at $60.42 on the Nasdaq on Wednesday.
(Reporting by Amrutha Penumudi in Bengaluru; Editing by Saumyadeb Chakrabarty and Maju Samuel)
- Health
- Pharmaceuticals Drug Trials
- major depressive disorder
- Alkermes