FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

...incidence greater than or equal to 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder. "INVEGA SUSTENNA provides healthcare professionals the opportunity to rethink their overall approach to how they t...

New Data Demonstrate RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment May Improve Health Outcomes and Reduce Hospitalizations in Patients with Schizophrenia

...50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%). * akathisia and restlessness + Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia Weight Gain: In a 12-week trial, the...

FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder

...50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%). * akathisia and restlessness + Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia Weight Gain: In a 12-week trial, the...

Aplenzin(TM), the Only Single Tablet Once-Daily Treatment for Depression at All Doses, Now Available in the United States

... should monitor patients for suicidality as well as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, and other unusual changes in behavior. All patients should be closely monitored for these symptoms, esp...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

...bo on the HAM-D-21 (p<0.001). The most common adverse events occurring in this trial were: headache (32%), dizziness (18%), insomnia (14%), akathisia (13%) and dyspepsia (12%). The study was sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC. Paliperidone ER, an atypical antipsyc...

ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old

...), fatigue (ABILIFY: 11%; placebo: 4%), nausea (ABILIFY: 11%; placebo: 4%), akathisia (ABILIFY: 10%; placebo: 2%), blurred vision (ABILIFY: 8%; placebo: 0%), sal...%), somnolence (ABILIFY 10 mg: 19.4%; ABILIFY 30 mg: 26.3%; placebo: 3.1%), akathisia (ABILIFY 10 mg: 8.2%; ABILIFY 30 mg: 11.1%; placebo: 2.1%) and salivary hyp...

INVEGA(TM) Shows Favorable Long-Term Safety Profile in a One-Year Study of Patients With Schizophrenia

...rred with an incidence of 8 percent or more were tremor (13 percent; n=31), akathisia (11 percent; n=25), headache (8 percent; n=19), and insomnia (8 percent; n=...ocardiograms and EPS incidence using the Simpson Angus Rating Scale, Barnes akathisia Rating Scale and Abnormal Involuntary Movement Scale. Efficacy was evaluate...

FDA approves ABILIFY(R) (aripiprazole) as the first medication for add-on treatment of MDD

...(incidence greater than or equal to 5 percent and at least twice the incidence of placebo plus ADT) associated with the use of adjunctive ABILIFY were akathisia (25 percent vs 4 percent), restlessness (12 percent vs 2 percent), insomnia (8 percent vs 2 percent), constipation (5 percent vs 2 percent), fatigue (...

ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration

... ABILIFY vs placebo, respectively): -- Adult patients with schizophrenia: akathisia (8 percent vs 4 percent) -- Pediatric patients (13 to 17 years) with sch...t patients with bipolar mania: constipation (13 percent vs 6 percent), akathisia (15 percent vs 3 percent), sedation (8 percent vs 3 percent), tremor (...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia

...r ABILIFY vs placebo, respectively): -- Adult patients with schizophrenia: akathisia (8 percent vs 4 percent) -- Pediatric patients (13 to 17 years) with schiz...lt patients with bipolar mania: constipation (13 percent vs 6 percent), akathisia (15 percent vs 3 percent), sedation (8 percent vs 3 percent), tremor (7...

Akathisia in Medical Technology

Antipsychotic Iloperidone Results Show Favorable Akathisia Profile

SAN DIEGO, May 22, 2007 /PRNewswire-FirstCall/ -- According to study results presented today at the 2007 American Psychiatric Association annual meeting, iloperidone, an investigational atypical antipsychotic, was shown to have a favorable akathisia profile. Akathisia -- a debilitating sensation o...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

...incidence greater than or equal to 5% and occurring at least twice as often as placebo) were injection site reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder. "INVEGA(R) SUSTENNA(TM) provides healthcare professionals the opportunity to rethink their overall approach to h...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

...vements Scale). There was a modest but significant worsening at endpoint in akathisia symptoms (assessed using the Barnes akathisia Scale) for lurasidone versus placebo. Lurasidone was well-tolerated ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

...or lurasidone (greater than 5% and at least twice the rate of placebo) were akathisia (17.6% vs. 3.1% placebo), somnolence (11.7% vs. 5.5%), parkinsonism (6.8% v...he rate of placebo among the combined lurasidone doses in these trials were akathisia (11.6% vs. 4.7% placebo), somnolence (14.3% vs. 7.1%) and nausea (14.8% vs....

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

...50 mg of RISPERDAL(R) CONSTA(R) and placebo, respectively, were akathisia* (4%, 11%, 6%), Parkinsonism+ (8%, 15%, 9%) and tremor (0%, 3%, 0%). * akathisia and restlessness + Extrapyramidal disorder, musculoskeletal stiffness, muscle rigidity, and bradykinesia Weight Gain: In a 12-week trial, the...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... other drugs in this class. Fanapt(TM) has a low incidence of extrapyramidal symptoms (movement disorders and tremors) and a placebo-like rate of akathisia (restlessness, inability to sit still), which are adverse events that are often associated with some other drugs in the class of atypical antipsychoti...

Major Restless Legs Study Completes Enrollment With Support From MediciGlobal

...orted by a very experienced MediciGlobal team." Restless Legs Syndrome (RLS) involves an irresistible urge to move the legs (medically known as akathisia ). It is estimated that 7% to 10% of the general population is affected by RLS and 60% of cases are inherited. A serious and common side effect is sle...

Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder

...iprazine and 38% for patients receiving placebo. The most common adverse events observed in the study were headache, extrapyramidal disorders, nausea, akathisia and constipation. Cariprazine was generally well tolerated with discontinuations due to adverse events observed in 14% of the cariprazine group and 10...

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

...ater than or equal to 5 percent and twice the rate of placebo) among patients taking asenapine in the short-term schizophrenia trials were somnolence, akathisia (restlessness) and oral hypoesthesia (numbness). "Schizophrenia is a lifelong illness that requires ongoing treatment to effectively manage the spec...

Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events

...orsening EPS (13.5% for iloperidone vs. 36.4% for haloperidol; p<0.001) and akathisia (9.2% for iloperidone vs. 23.7% for haloperidol; p<0.001). There were no cl...erity (CGI-S) (5) Clinical Global Impression of Change (CGI-C) (6) Barnes akathisia Scale (BAS) (7) Extrapyramidal Symptom Ratings Scale (ESRS) ...

Akathisia in Biological Technology

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)

...nce of placebo plus ADT) associated with the use of adjunctive ABILIFY were akathisia (25 percent vs 4 percent), restlessness (12 percent vs 2 percent), insomnia... placebo, respectively): -- Adult patients with major depressive disorder: akathisia (25 percent vs 4 percent), restlessness (12 percent vs 2 percent), inso...