A long-acting depot formulation of the antipsychotic drug olanzapine (Zyprexa) has been approved by the FDA, which had rejected the same product early last year.

The new version, to be marketed as Zyprexa RelPrevv, is given by intramuscular injection every two to four weeks, depending on the dose, and is now approved for treatment of schizophrenia in adults. Olanzapine was previously approved in oral and injectable forms for daily use.

In March of 2008, the FDA had rejected an earlier application from the drug’s manufacturer, Eli Lilly, citing concerns about an unusual side effect now called post-injection delirium/sedation syndrome (PDSS). (See FDA Rejects Olanzapine (Zyprexa) Depot for Schizophrenia)

Patients experiencing PDSS have walked into walls and fallen asleep in public places after receiving injections, usually within the first hour or two. Other reported symptoms included agitation, anxiety, and confusion.

In February 2008, the FDA’s advisory committee on psychiatric drugs recommended approval of the drug, despite PDSS, which then was called “excessive sedation events.” (See FDA Panel Gives Qualified Okay to Depot Olanzapine (Zyprexa))

Although the FDA usually follows committee recommendations, it decided to reject the product after Lilly reported that another PDSS case had occurred.

The company said Monday that, on the basis of the experience of more than 2,000 patients, the syndrome has developed in about 2% of patients and less than 0.1% of injections.

The FDA and Lilly have now agreed on a risk evaluation and mitigation strategy to limit problems associated with PDSS.

The labeling includes a requirement that patients stay under observation at a healthcare facility for at least three hours after each injection and have an escort when leaving the facility.

At the 2008 advisory committee meeting, some panel members had expressed reservations about such a requirement, noting that many clinics did not have the space or staff to supervise patients for hours.

Patients, physicians, clinics, and pharmacists dispensing the depot product must also register in a “patient care program” to educate them about the risks of PDSS. The program includes a patient medication guide as well as plans to inform providers about safe use of the Zyprexa RelPrevv. The label states that the product is never to be given directly to patients.

Other side effects of the depot version of olanzapine were similar in nature and frequency to those seen with the daily pills and injections.

These include weight gain, dyslipidemia, hyperglycemia, and orthostatic hypotension.

Related Article(s):

• FDA Rejects Olanzapine (Zyprexa) Depot for Schizophrenia
• FDA Panel Gives Qualified Okay to Depot Olanzapine (Zyprexa)

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