Results from Olanzapine Long-Acting Injection Studies Revealed
Results from a 24-week maintenance study and interim findings from an ongoing open-label study of olanzapine long-acting injection (LAI), presented at the annual Schizophrenia International Research Society conference, showed that the efficacy and safety profile of olanzapine LAI was generally consistent with that of Zyprexa® (olanzapine) with the exception of injection-related events. Olanzap-ine LAI is an investigational formulation that combines olanzapine with a pamoate salt, resulting in an extended delivery of up to 4 weeks.
In the 24-week double-blind maintenance study, 1,065 adult outpatients with schizophrenia who had been stabilized previously on open-label oral olan-zapine (10, 15, or 20 mg daily) for 4 to 8 weeks were randomized to one of three therapeutic dosing regimens of olanzapine LAI (150 mg every 2 weeks, 405 mg every 4 weeks, or 300 mg every 2 weeks) or to a low reference dosage of olanzapine LAI (45 mg every 4 weeks), or remained on oral olanzapine at their previously stabilized dosage.
Patients remained free of relapse, as assessed by the Brief Psychiatric Rating Scale, at a rate of 95% with 300 mg/2 weeks, 90% with 405 mg/4 weeks, and 84% with 150 mg/2 weeks of olanzap-ine LAI. Comparatively, 93% of patients receiving oral olanzapine remained free of relapse during the study. All three higher olanzapine LAI dosages had longer time to relapse than did the reference dosage (p < 0.01).
During an ongoing open-label extension trial of olanzapine LAI, 931 adult patients with schizophrenia or schizoaffective disorder who had previously participated in one of three randomized, controlled studies of olanzapine LAI received flexibly dosed olanzapine LAI at intervals of approximately 2 to 4 weeks. Treatment response was measured by the Clinical Global Impression Severity of Illness scale; baseline-to-endpoint mean change on this scale was –0.16, from a baseline of 2.92. At week 160, the discontinuation rate was low (39.6%)
For both studies, adverse events reported in 5% or more of patients were insomnia, weight increase, anxiety, nasopharyngitis, somnolence, and headache. In the maintenance study, 2 patients experienced and recovered fully from Post-Injection Delirium/Sedation Syndrome (PDSS). At the time of the interim analysis of the ongoing open-label trial, 23 PDSS events were reported in 22 patients. Between September 30, 2007, and May 31, 2008, four additional events have been reported in the ongoing trial.
Source. “Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society Conference.” (2008, June 23). Retrieved August 5, 2008, from http://www.medicalnewstoday.com/articles/112440.php.
Antidepressant Drugs Frequently Prescribed for Bipolar Disorder
More than half (52.3%) of newly diagnosed bipolar disorder patients are prescribed antidepressant drugs as first-line therapy, according to “Treatment Algorithms in Bipolar Disorder,” a report from pharmaceutical and health care research firm Decision Resources. Surveyed primary care physicians specified selective serotonin reuptake inhibitors (including Lexapro® [escitalopram oxalate]) as a favored first-line treatment choice for patients with bipolar disorder I with acute depression (51% of surveyed physicians), bipolar disorder II with acute depression without hypomania (52% of surveyed physicians), and bipolar disorder II with acute depression with hypomania (46% of surveyed physicians).
The report also found that Lamictal® (la-motrigine) is the leading single agent in first-line, second-line, and third-line therapy, amassing 18%, 13.8%, and 16.3% patient share in each line of therapy, respectively. The majority of surveyed psychiatrists preferred Lamictal for first-line treatment of patients with bipolar disorder I with acute depression (59% of surveyed psychiatrists) and bipolar disorder II with acute depression and no hypomania (61% of surveyed psychiatrists). Lamictal and Depakote® ER (dival-proex sodium) were frequently prescribed first line by surveyed psychiatrists for bipolar disorder II patients with acute depression and hypomania (45% and 32% of surveyed psychiatrists, respectively).
Source. “Astonishing 52 Percent of Newly Diagnosed Bipolar Disorder Patients Receive Antidepressant Drugs in First-Line Treatment.” (2008, August 11). Retrieved August 22, 2008, from http://www.medicalnewstoday.com/articles/117914.php.
Light Technology Offers Relief from Insomnia
A glowing blue light could shine relief onto people experiencing insomnia, says Coherence Resources, Inc., developer of the NightWave™ Sleep Assistant. NightWave facilitates a state of relaxation through a simple pre-sleep breathing routine guided by a soft blue light projected into the darkened bedroom. The luminance of the light slowly rises and falls, and the user, with eyes open, synchronizes his or her breathing with the wave of light as its movement becomes slower and slower. After a short time, the person falls asleep and NightWave shuts off.
© Coherence Resources, Inc.
The device is based on the principles of deep breathing techniques, which activate the parasympathetic branch of the involuntary nervous system. During this relaxation response, muscle tension drops, stress levels decrease, heart rate variability becomes smooth, blood pressure normalizes, and mood softens.
NightWave, suggested for individuals who experience common insomnia due to stress, an overly active nervous system, restless thoughts, feelings of agitation, or jet lag, is silent, does not require wires or masks, and is drug free. The device retails for $69 plus shipping; JPN readers can receive a $20 discount by accessing http://www.nightwave.com and entering the coupon code CPN78322.
Source. “New Drug-Free Solution for Insomnia.” (2008, June 12). Retrieved August 5, 2008, from http://www.bio-medicine.org/medicine-news-1/New-Drug-Free-Solution-for-Insomnia-21708-1/.
Xenazine: First Approved Drug to Treat Chorea
Xenazine® (tetrabenazine) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chorea (jerky, involuntary movement) in individuals with Huntington’s disease, making it the first treatment of any kind approved in the United States for any symptom of Huntington’s disease and the first FDA-approved drug to treat chorea. Xenazine decreases the amount of dopamine available to work at relevant synapses in the brain, thereby decreasing the involuntary movements.
The effectiveness and safety of Xenazine was established primarily in a randomized, double-blind, placebo-controlled, multicenter clinical trial. Patients treated with Xenazine had a significant improvement in chorea compared with patients treated with placebo.
The most common side effects reported by patients taking Xenazine included insomnia, depression, drowsiness, restlessness, and nausea. Serious side effects reported with Xenazine use included depression and suicidal thoughts and actions. Concerns about the risk of suicide are heightened in all patients with Huntington’s disease.
Although Xenazine showed a decrease in chorea in the short term, it also showed slight worsening in mood, cognition, rigidity, and functional capacity in clinical trials.
Source. “FDA Approves First Drug Treatment for Chorea in Huntington’s Disease.” (2008, August 15). Retrieved August 22, 2008, from http://www.fda.gov/bbs/topics/NEWS/2008/NEW01874.html.
Depakote Now Available in Generic Form
The U.S. Food and Drug Administration (FDA) has approved the first generic versions of Depakote® (divalproex sodium) delayed-release tablets. Depakote is approved by the FDA for the treatment of seizures, bipolar disorder, and migraine headaches.
Generic divalproex sodium will have the same safety warnings as Depakote, including a boxed warning that cautions about the risk of liver damage, including fatalities, and pancreatitis, including fatal cases. The boxed warning also highlights the risk of birth defects, including neural tube defects.
Source. “FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder.” (2008, July 29). Retrieved August 6, 2008, from http://www.fda.gov/bbs/topics/NEWS/2008/NEW01867.html.