Labopharm announces U.S. launch of OLEPTRO(TM) for treatment of major depressive disorder in adults
“The U.S. launch of our second product, OLEPTRO(TM), is a major milestone for Labopharm and represents a significant opportunity as we focus on driving revenue as a commercial enterprise,” said
The initial OLEPTRO(TM) sales force is composed of 145 individuals and can be scaled up as the product achieves market penetration. The sales effort is complemented by a managed care strategy that maximizes access for OLEPTRO(TM).
“OLEPTRO(TM) offers physicians another therapeutic alternative for treating their patients with major depressive disorder,” said Dr.
MDD is a common mental illness often characterized by a combination of emotional, somatic and behavioral symptoms.(i) It affects more than 14 million adults in the U.S. and is the leading cause of disability globally. Nearly 28 percent of patients being treated with antidepressants stop taking their medication within the first four weeks of treatment and as many as 44 percent stop within the first 12 weeks, due to reasons such as lack of efficacy, exacerbation of symptoms, including sleep disturbance and agitation, and/or adverse events such as weight gain or sexual dysfunction.(ii)
OLEPTRO(TM) is a novel once-daily formulation of the antidepressant trazodone for the treatment of major depressive disorder (MDD) in adults.
OLEPTRO(TM) is an extended release formulation of trazodone hydrochloride, and uses CONTRAMID(R), 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(R), 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 score 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(TM) in
Labopharm will discuss the launch of OLEPTRO(TM) during its previously announced conference call to discuss its second quarter fiscal 2010 financial results on
About Labopharm Inc.
Important Safety Information About OLEPTRO(TM)
For more complete information about OLEPTRO(TM), 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(TM) 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, nauseam vomiting and/or diarrhea. OLEPTRO(TM) 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, OLEPTROTM dose should be decreased gradually and patients monitored for symptoms.
Pregnancy Category C: OLEPTROTM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Please see the full Prescribing Information for OLEPTROTM 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(TM).
This press release contains forward-looking statements, including statements concerning the commercial potential of OLEPTRO(TM) in
OLEPTRO(TM) is a trademark of Labopharm Inc.
CONTRAMID(R) is a registered trademark of Labopharm Inc.
----------------------------- (i) Bostwick, J.M., A Generalist's Guide to Treating Patients with Depression with an Emphasis on Using Side Effects to Tailor Antidepressant Therapy. Mayo Clin Proc. 2010;85(6):538-550 (ii) Lin E.H. et al. Medcare.1995;33:67-74
SOURCE Labopharm Inc.