A US Food and Drug Administration Advisory Committee has supported the approval of a long-acting form of Eli Lilly’s antipsychotic Zyprexa, despite concerns over excessive sedation side effects in some patients.

Zyprexa LAI (olanzapine) is an injectable form of the drug that provides extended delivery of up to four weeks, but, in clinical trials, 24 out of 1,915 patients who received the jab suffered excessive sedation, which typically lasted around one to three hours and even induced coma in two cases. All patients suffering these side effects fully recovered within 72 hours.

However, after reviewing all the evidence, the Psychopharmacologic Drugs Advisory Committee voted that, with appropriate labeling to describe such excessive sedation events observed in trials, the injectable drug is effective for the acute and long-term treatment of schizophrenia and is “acceptably safe”.

Compliance benefits
One of the main problems with schizophrenia therapy is that patients often fail to stick to their drug regimens, which can lead to relapses of the illness, and it is hoped that a long-acting injection of Zyprexa will help to overcome this by effectively boosting treatment compliance. “Long-acting injectable antipsychotics can help patients derive more consistent benefits from their medications,” explained Dr John Kane, chairman of the Department of Psychiatry at The Zucker Hillside Hospital in Glen Oaks, New York.

And John Hayes, vice president of Lilly Research Laboratories, remarked: "Due to the chronic and severe nature of the illness and the limited number of approved long-acting formulations, we believe that, if approved, Zyprexa LAI could be an important treatment option for this patient population, who struggle with taking their medication.”

Oral and short-acting injection forms of the drug pulled in almost $4.8 billion for the company last year, and analysts believe that the long-acting formulation could smash the $1-billion barrier.