Princeton, NJ (Vocus) November 22, 2010
This week at the 2010 U.S. Psychiatric and Mental Health Congress in Orlando, FL, Angelini Labopharm presented two analyses from the pivotal clinical trial for OLEPTRO™ (trazodone hydrochloride) extended-release tablets which examined its effect in patients with major depressive disorder (MDD). The first analysis reported on the primary endpoint of the study which was the change in the HAMD-17 from baseline to week eight vs. placebo and was the basis for the FDA approval of OLEPTRO™. The second analysis, which was a post hoc analysis from the pivotal study, demonstrated OLEPTRO™’s antidepressant effect was independent of a patient’s baseline level of sleep disturbance or severity of depression.
Almost one third of MDD patients being treated with antidepressants stop taking their medication within the first month of treatment, and as many as 44 percent stop within the first three months. Discontinuation of therapy can be due to a variety of reasons, but most common are sleep disturbance, agitation, weight gain or sexual dysfunction. In the pivotal trial, less than five percent of patients treated with OLEPTRO™ reported sexually-related side effects, and there was no notable change in weight vs. placebo.
“These data on OLEPTRO™ are quite important because treating major depressive disorder continues to be a challenge for physicians,” said Dr. David Sheehan, Director of Depression and Anxiety Disorders Research Institute, University of South Florida College of Medicine. “Patients with depression respond to treatment very differently. OLEPTRO™ is an option that will allow physicians to treat MDD.
About Major Depressive Disorder
MDD is a common mental illness often characterized by a combination of emotional, somatic, and behavioral symptoms. It affects more than 14 million adults in the U.S. and is the leading cause of disability globally. Approximately two times more prevalent in wome than men, MDD often co-exists with other illnesses. Research shows that only approximately 65 percent of individuals with MDD are diagnosed and, of those patients, 90 percent are treated with medication.
OLEPTRO™ is a novel once-daily formulation of the antidepressant trazodone for the treatment of major depressive disorder (MDD) in adults.
OLEPTRO™ is an extended release formulation of trazodone hydrochloride, and uses Contramid®, Labopharm’s clinically validated technology to control the release of active substances within oral medications, whether taken whole or when broken along the score line. Contramid®, which allows for a high drug-loading capacity, forms a semi-permeable membrane that controls the release of medication throughout a 24 hour time period. The tablets may also be broken in half along the scored line without compromising the extended release properties due to a membrane that forms across the new inner surface of the broken tablet.
About Angelini Labopharm
For the purpose of marketing OLEPTRO™ in the United States, Angelini and Labopharm established the joint venture Angelini Labopharm, which is equally owned by both companies. This partnership leverages Labopharm’s Contramid® technology platform with Angelini’s experience of the trazodone molecule.
Important Safety Information About OLEPTRO™
For more complete information about OLEPTRO™, please see the full Prescribing Information and Medication Guide available at http://oleptro.com.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. OLEPTRO™ is not approved for use in pediatric patients.
Warnings and Precautions
Please see full prescribing information for complete description of Warnings and Precautions.
Clinical Worsening/Suicide Risk: Patients should be monitored for clinical worsening and suicidal thinking and behavior.
Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions: Have been reported with antidepressants. Symptoms: agitation, hallucinations, coordination problems, fast heart rate, tight muscles, trouble walking, nausea, vomiting and/or diarrhea. OLEPTRO™ use should be discontinued.
Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/ hypomania. Symptoms: feeling high or in a very good mood, then becoming irritable or having too much energy, feeling the need to keep talking or not sleeping (Mania).
QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval.
Use in Patients with Heart Disease: Use with caution in patients with cardiac disease.
Orthostatic Hypotension and Syncope: Have occurred. Patients should be made aware of risk and symptoms of hypotension (dizziness or faintness when changing positions).
Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk.
Interaction with MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors.
Priapism: (erection lasting more than six hours) Has occurred. Male patients should be warned of this risk and how/when to seek medical attention.
Hyponatremia: (Low sodium in the blood) Can occur. Symptoms: headache, feeling weak and/or confused, trouble concentrating, memory problems, feeling unsteady when walking. Elderly patients, patients taking diuretics or patients who are dehydrated can be at greater risk.
Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Patients should use caution when operating machinery.
Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, OLEPTRO™ dose should be decreased gradually and patients monitored for symptoms.
Pregnancy Category C: OLEPTRO™ should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see the full Prescribing Information for OLEPTRO™ for information about potential drug interactions.
The most common adverse reactions (incidence greater than or equal to five percent and twice that of placebo) are: somnolence/sedation, dizziness, constipation, blurred vision. These are not all the possible adverse events of OLEPTRO™.
OLEPTRO™ is a trademark of Labopharm Inc.
© 2010, Angelini Labopharm.
All rights reserved. OLP0136 11/10.
Source: Angelini Labopharm
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