May 2008

Three IM Antipsychotics
New intramuscular (IM) formulations of second-generation antipsychotics appear comparable and possibly superior in efficacy and safety to older agents, but are more expensive.

Baclofen for Alcohol Dependency with Liver Cirrhosis
Baclofen (Lioresal and others) shows efficacy in treating alcohol dependency with no adverse hepatic effects.

Antipsychotics to Treat Aggression in Patients with Intellectual Disability
A double-blind study finds little evidence to support the use of antipsychotics to treat aggression in patients with intellectual disability.

In Brief
Desvenlafaxine Approved for Depression; Olanzapine LAI Not Approved for Schizophrenia

Depression Infrequently Treated
Many patients with depression worldwide do not receive effective care.

Clozapine Plus Aripiprazole
Aripiprazole (Abilify) may be beneficial for patients with schizophrenia who respond only partially to clozapine (Clozaril and others).

In Brief

May 2008

In February, the US Food and Drug Administration (FDA) approved the new serotonin-norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Pristiq) for the treatment of major depressive disorder in adult patients (Wyeth press release, February 29, 2008. Available at: Accessed March 26, 2008). Desvenlafaxine is the major active metabolite of venlafaxine (Effexor). Both drugs are manufactured by Wyeth Pharmaceuticals. Desvenlafaxine will be available in a 50-mg, once-daily dose that does not require titration. FDA approval was contingent on Wyeth agreeing to conduct several post-marketing studies, including studies of desvenlafaxine's effects during long-term maintenance, on sexual dysfunction, in pediatric patients, and at lower doses. We will review the double-blind studies of desvenlafaxine that established its efficacy for depression in the June issue of BTP.

The FDA has not approved Eli Lilly's long-acting injection (LAI) formulation of olanzapine (Zyprexa) for the treatment and maintenance treatment of schizophrenia in adults (Lilly product news release, February 28, 2008. Available at: Accessed March 26, 2008). Olanzapine LAI combines olanzapine with a parnoate salt, which gives it a delivery time of up to 4 weeks. In about 1% of patients in clinical trials, excessive sedation events occurring within 3 hours of injection were observed. At the end of an FDA Psychopharmacologic Drugs Advisory Committee hearing at which these sedation events were discussed, the committee voted that "there were circumstances under which Zyprexa LAI would be acceptably safe and effective for the treatment of acutely exacerbated schizophrenia and maintenance treatment of schizophrenia in adults." However, another excessive sedation event occurred on the day of that meeting. This adverse event began between 3 and 5 hours after injection of olanzapine LAI. In a "not approvable letter," the FDA requested more information to clarify the risk and underlying cause of these events. All patients who experienced a sedation event recovered fully.

Heather S. Hopkins