INDIANAPOLIS--29 Sep--PRNewswire-AsiaNet/InfoQuest
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral
The opinion issued by the CHMP will need to be ratified by the European Commission before the new indication is considered approved. The Commission usually makes a decision within two to three months of a CHMP recommendation.Olanzapine long-acting injection (LAI) is an investigational formulation that combines olanzapine, an atypical antipsychotic, with pamoic acid resulting
"Because of the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of depot formulations available, we believe that olanzapine long-acting injection has the potential to become a valuable treatment option for patients," said David McDonnell, M.D., clinical research physician at Lilly.
The CHMP opinion was based on a comprehensive data package comprising eight studies, involving 2,054 patients, including a double-blind, placebo-controlled, fixed-dose study (HGJZ)(ii); a double-blind, oral olanzapine-controlled, fixed-dose study (HGKA)(iii); and six open-label studies(iv). In these trials, olanzapine long-acting injection was found to be similar to olanzapine oral in terms of rate of symptom exacerbation and showed a similar safety profile as the oral formulation with the exception of injection-related events, including olanzapine LAI Post-Injection Syndrome(V).
Additionally, the trials showed that olanzapine long-acting injection (LAI) separated from placebo as measured by total PANSS score reduction over 8 weeks of treatment, and a drug effect that was observed as early as one week from the first injection(vi). Olanzapine long-acting injection was studied as a once-every-four-week and a once-every-two-week injection, without the need for
As of August 31, 2008, across all clinical trials, olanzapine LAI Post-Injection Syndrome events, including a range of symptoms of sedation (from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment), have been seen in 0.07 percent of injections and 1.4 percent of patients, all of whom have recovered fully(vii).
As part of the marketing authorization, Lilly has proposed a comprehensive risk minimization plan for identifying and managing olanzapine LAI Post-Injection Syndrome. The plan includes a requirement for a post-injection observation period described in the product labeling, and an extensive healthcare provider training and educational program.
Earlier this month, Zypadhera was approved for use in New Zealand. Independent regulatory reviews of olanzapine LAI applications for schizophrenia are ongoing in the United States, Canada, Australia and other countries.
Notes for editors:
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 when a patient expresses a preference for such treatment due to convenience or if it is determined that a depot formulation is
Long-acting antipsychotic formulations have been associated with improved treatment adherence and reduced treatment failures.(ix) 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.(x) Different from both oral
About Schizophrenia
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
About Olanzapine
Since olanzapine was introduced in 1996, it has been prescribed to more than 26 million people worldwide. Olanzapine is not recommended for use in patients under 18 years of age.
In Europe, olanzapine is indicated for schizophrenia and in clinical trials, it has shown to be effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. It also is indicated for the treatment of moderate to severe manic episodes and, in those patients whose manic episode has responded to olanzapine
SAFETY INFORMATION
Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases. In some cases, a prior increase in body weight has been reported, which may be a predisposing factor. Appropriate clinical monitoring is advisable, particularly in diabetic patients and in patients with risk factors
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported rarely 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 increases as the duration of treatment. If signs and symptoms of TD are observed a dose reduction or discontinuation should be considered and it should be noted that the symptoms can temporally deteriorate or even rise after
Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, thromobembolism, neutopenia, sweating, insomnia, tremor, anxiety, nausea, or vomiting.Olanzapine should not be used in patients who have a hypersensitivity to the drug nor those with narrow angle glaucoma. It should not be used to treat dementia-related psychosis and/or behavioural disturbances because of an observed increase in death and cerebrovascular accident. It should also not be used in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease.
The most frequently (seen in >/= 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases, rash, asthenia, fatigue and oedema.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.co.uk
P-LLY
This press release contains forward-looking statements about the safety and efficacy of olanzapine long acting injection (LAI) and reflects Lilly's current beliefs. However, as with any investigational pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, regulatory milestones and commercialization. There is no guarantee that
i. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics
ii. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell
iii. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D.
iv. McDonnell D., Andersen S., Detke H., Watson S. 160-week interim results
v. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D.
vi. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell
vii. McDonnell D., Sorsaburu S., Brunner E., Detke H., Andersen S.,
viii. Falkai P., Wobrock T., Lieberman J., Glenthoj B.,Gattaz W.F., Moller
x. Kane J.M et al. Guidelines for depot antipsychotic treatment in
xii. American Psychiatric Association. Diagnostic and Statistical Manual of
SOURCE Eli Lilly and Company
CONTACT: Janell Smith, +1-317-277-9603 (office), +1-317-358-5396 (mobile),
[email protected], or Charlie McAtee, +1-317-277-1566 (office),
+1-317-997-1627 (mobile), [email protected], both of Eli Lilly and Company
Photo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
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Web site: http://www.lilly.co.uk
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