Lilly receives complete response letter for Olanzapine LAI for treatment of schizophrenia
It’s debilitating, isolating and can lead to severe depression - yet pain is widely accepted as something to be expected and regarded as ‘normal’ in later life. Now a new study from The University of Nottingham examines older people’s experiences of pain and how best Government, the NHS and social care agencies can address the
Full Post: New study examines the experiences of older people
Eli Lilly and Company has announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults.
Lilly is continuing to work with the agency on the new drug application (NDA).
The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency’s request, Lilly is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will be submitted in the near future.
“We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness,” said Todd Durell, M.D., associate medical director for U.S. neuroscience for Lilly.
This treatment has been approved for use in the European Union and New Zealand under the trade name Zypadhera(TM). Independent regulatory reviews are ongoing in other countries.About Long-acting Injectable Antipsychotic Medications
The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia. Depot formulations should be considered as a treatment option if it is determined that a depot formulation is necessary to help with compliance.
By administering long-acting medications, healthcare professionals know when patients have received their medication and can immediately detect non- adherence when a patient fails to return for a scheduled injection. Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.
Schizophrenia is a severe and debilitating illness with such symptoms as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months. In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.
Safety information for Zyprexa
Zyprexa oral is indicated in the United States for the short- and long- term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder.Olanzapine is not approved for the treatment of patients with dementia- related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with olanzapine.
Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics, including olanzapine. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking olanzapine should be monitored regularly for worsening of glucose control. Persons with diabetes who are started on atypicals should be monitored regularly for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.
Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using olanzapine, is advised. Significant, and sometimes very high, elevations in triglyceride levels have been observed with olanzapine use. Significant increases in total cholesterol have also been seen with olanzapine use.
Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight.
Olanzapine may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular caution should be used in patients with known cardiovascular disease, cerebrovascular diseases, or those predisposed to hypotension.
As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Other potentially serious adverse events include seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation, and trouble swallowing.
The most common treatment-emergent adverse event associated with oral Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.
Schizophrenia and bipolar disorder have for decades been regarded as two distinct psychotic disorders when it comes to definitions and risk factors. Schizophrenia is a psychotic illness that causes delusions and hallucinations - bipolar disorder also known as manic depression, causes extreme mood swings from deep depression to manic episodes. But now a study by
Full Post: Schizophrenia and bipolar disorder have same genetic causes
American pharmaceutical giant Eli Lilly and Company has agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA), the Department of Justice announced. This resolution includes a criminal fine of $515 million, the largest ever in a health care case, and the
Full Post: Eli Lilly to pay $1.415 billion for off-label promotion of Zyprexa
Emory University in Atlanta is playing a key role in the largest, most comprehensive study ever funded by the National Institute of Mental Health (NIMH) of adolescents and young adults at risk for developing a psychotic disorder. The five-year, $25-million study joins the resources of Emory and seven other major research universities, with the goal
Full Post: New study focuses on adolescents and young adults at risk for psychosis
Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-week study. Statistical significance was evidenced at all doses tested (25, 100, and 150 mg equivalent [eq.a]), when given every 4 weeks with a 150 mg eq. initiation dose. A separate 53-week non-inferiority trial(b)
Full Post: Paliperidone palmitate shows positive results for treatment of schizophrenia
Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. The action letter includes proposed
Full Post: FDA issues complete response letter for SAPHRIS (asenapine) sublingual tablets in acute treatment of schizophrenia and bipolar disorder