NEW YORK (AP) — Forest Laboratories Inc. said regulators want more information on the drugmaker’s potential schizophrenia treatment cariprazine before they decide whether to approve the drug.
The New York company said Thursday the Food and Drug Administration indicated that additional clinical trial data would be needed. Forest said it believes this request was made to better define the best dosing regimen to maintain the drug’s effectiveness while minimizing side effects. Forest and Hungarian drugmaker Gedeon Richter PLC plan to meet with FDA officials to discuss next steps.
Gedeon Richter developed cariprazine and then licensed it to Forest in the United States and Canada.
Forest submitted cariprazine to the FDA for approval nearly a year ago.
The potential drug aims to treat bipolar I disorder, which is also known as manic-depressive illness and characterized by unusual shifts in a person’s mood, energy level or ability to carry out daily tasks. It also treats schizophrenia, a condition with symptoms that include hallucinations, delusions and social withdrawal.
Cariprazine’s side effects include restlessness, tremors, an upset stomach, and vomiting.
Forest shares fell 10 cents to $51.32 in morning trading Thursday. They have risen more than 45 percent so far this year.