LABOPHARM RECEIVES HEALTH CANADA APPROVAL FOR OLEPTRO(TM): A NEW ONCE-DAILY ANTIDEPRESSANT FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
- Company Advancing Partnership Discussions and Preparing for Canadian Launch -
“We are pleased to announce the approval of OLEPTRO(TM) in
MDD is a common mental illness often characterized by a combination of emotional, somatic and behavioral symptoms.(1) Approximately 1.6 million Canadians suffer from depression in a given year and more than one in ten Canadians over the age of 15 will suffer from depression during their lifetime. The incidence is highest among women and in younger age groups, and the strongest risk factor is having a family history of major depression. Depression is one of the leading causes of disability globally. Sales of antidepressants in
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.(2)
“OLEPTRO(TM) offers Canadian physicians a therapeutic alternative for treating their patients with major depressive disorder, one that combines the mechanism of action of a serotonin antagonist reuptake inhibitor, or SARI, with a novel once-daily dosing option,” said Dr.
OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm’s clinically validated technology that controls the release of active substances within oral medications.
“An important factor often arising in the clinical management of depression is the need to switch antidepressants or to prescribe additional medications to address antidepressant-induced side effects such as sexual dysfunctions and poor quality of sleep,” commented Dr
About the OLEPTRO(TM) Pivotal Study
An eight-week randomized, double-blind, two-arm, multi-centre study in patients with unipolar major depressive disorder demonstrated OLEPTRO(TM)’s efficacy as a treatment for depression. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the OLEPTRO(TM) group versus the placebo group. The results of this study, which were published in the
- The change from baseline in mean HAMD-17 total score was seen as early as week 1 and throughout the 8-week study vs. placebo (p less than 0.05) (full antidepressant effect may take 4 to 6 weeks); - No notable weight gain and a low incidence of sexual dysfunction; - The most common adverse events (incidence greater than or equal to 5% and twice that of placebo) were somnolence/sedation, dizziness, constipation and blurred vision; - In the OLEPTRO(TM) group, only 4 percent of patients discontinued treatment due to somnolence or sedation; - Statistical significance was achieved for the majority of prespecified secondary endpoints.
OLEPTRO(TM) is a novel once-daily formulation of the antidepressant trazodone hydrochloride for the symptomatic relief of major depressive disorder (MDD) in adults. It uses CONTRAMID(R), Labopharm’s clinically validated technology that controls the release of active substances within oral medications and which allows for a high drug-loading capacity. The tablets may be broken in half along the score line without compromising the extended release properties. As a formulation of trazodone, OLEPTRO(TM)’s mechanism of action is such that it acts as an antagonist at different families of serotonin receptors in addition to acting as an inhibitor of serotonin reuptake.
OLEPTRO(TM) was approved for the treatment of major depressive disorder in adults and launched in
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company’s commercialized products include OLEPTRO(TM), a once-daily antidepressant marketed in the U.S. (and approved in
This press release contains forward-looking statements, including statements concerning the ability of the Company to find a distribution partner for OLEPTRO(TM) in
OLEPTRO(TM) is a trademark of Labopharm Inc. CONTRAMID(R) is a registered trademark of Labopharm Inc.
--------------------------------- (1) 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 (2) Lin E.H. et al. Medcare.1995;33:67-74
SOURCE Labopharm Inc.