(Reuters) - Alkermes Plc’s schizophrenia drug met its main goal of keeping in check a common side effect of antipsychotic medicines - weight gain - taking the company one step closer to a marketing approval for the treatment.
Data from a late stage trial showed that patients on Alkermes’ drug had a mean weight gain of 4.21 percent after six months, compared with an average gain of 6.59 percent in patients receiving olanzapine, the most commonly used antipsychotic drug.
However, some analysts questioned the extent to which the drug was able to reduce weight gain.
The relatively small difference in weight gain between the two groups may dampen physician excitement about the drug, Citi analyst Liav Abraham said, noting that weight gain was the most common reason for patients dropping out of the study.
The company’s shares fell as much as 3.7 percent before recovering to trade marginally higher.
The drug, ALKS 3831, is a tablet composed of Alkermes’ new drug samidorphan and olanzapine, and is designed to provide the antipsychotic effect of olanzapine while mitigating its associated weight gain, the company said on a conference call.
Stifel analyst Paul Matteis said the results were decent, but not a game-changer in schizophrenia, adding that the drug is likely to garner some use at the right price.
“Patients on ‘3831 still gained a decent amount of weight, plausibly more than one might observe on other atypical antipsychotics outside of olanzapine,” Matteis said in a note.
The company suffered a setback earlier this month when its other samidorphan-based drug, developed as an add-on treatment for major depression, was strongly voted against approval by an advisory panel to the FDA earlier this month.
Schizophrenia is a chronic, severe and disabling brain disorder, marked by hallucinations and depression. About 2.4 million American adults suffer from the disorder.
The Dublin-based company said it plans to submit the marketing application for the drug to the U.S. Food and Drug Administration in mid-2019.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Anil D'Silva and Saumyadeb Chakrabarty