Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepre... (toplacebo in patients with major unipola...)

Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug

Date:9/25/2007

to placebo in patients with major unipolar depressive disorder. The study, which has a treatment period of approximately two months, is being conducted at more than 35 centers across the U.S. and Canada.

Pharmacokinetic trials have demonstrated that Labopharm's once-daily formulation of trazodone has controlled-release properties over a 24-hour period.

Based on discussions with U.S. Food and Drug Administration (FDA), Labopharm expects to submit a New Drug Application (NDA) for its once-daily formulation of trazodone under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act, which typically applies to reformulations of drugs that are already approved and being marketed, allowing the Company to leverage existing efficacy and safety data on trazodone. Under this Section of the Act, one positive Phase III study is required for the formulation to be approved by the FDA.

About Trazodone

Trazodone is an atypical anti-depressant that acts as a dual serotonin agonist and serotonin reuptake inhibitor (SARI). Trazodone appears to increase serotonin activity via three mechanisms: the activation of neuronal serotonin receptors; the inhibition at the neuronal serotonin feedback system which regulates the action of serotonin; and the inhibition of the re-uptake of serotonin. Trazodone also helps to treat depression by improving sleep as a result of sedative effects caused by activation of histamine receptors and initiation and restoration of deep sleep cycles as a result of serotonin receptor activation. This may be of clinical benefit in depressed patients who have agitation, insomnia or poor sleep quality associated with their depression. Depression is one of the most prevalent central nervous system disorders, affecting at least 121 million people globally. Trazodone is widely used in its treatment with more than 14 million prescriptions written in the U.S. alone in 2006.

About Labopharm's Once-Daily Formulation of Trazodone

I
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine news :

1. iGATE Completes Phase I Testing Of Meningitis Vaccine
2. Delhi Hospital Completes 100 Liver Transplants
3. Roche Completes Acquisition of BioVeris
4. FDA approves Phase 0 trial which tests experimental drugs on humans
5. SARS-Free Taiwan to Mark End Phase of Global Fight
6. S. Africa AIDS in death phase
7. Spray on contraceptive clears Phase I trial
8. Phase 3 trials of two multi-kinase inhibitors against cancer
9. Antigenics Pharmaceuticals plans for Phase III trial of its Melanoma vaccine
10. Phase II trails of new HIV vaccine to be held in South Africa
11. Phase 1 Drug Trials on Humans to Be Made Public

Post Your Comments:

Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepre...(toplacebo in patients with major unipola...),Health