Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Labopharm to submit once-daily trazodone

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Labopharm intends to file its once-daily version of the antidepressant trazodone using the 505(b)(2) pathway by the end of 2008, the firm said Feb. 8 after announcing positive Phase III results. Labopharm is touting the formulation's ability to "significantly improve the overall quality of sleep [with] less awakening at night." Labopharm believes that the once-daily option that reduces agitation and improves sleep quality will reduce the need for add-on therapies and be well-positioned in the antidepressant marketplace. Once-daily trazodone met the primary endpoint (HAMD-17) in the 8-week placebo-controlled study of 412 patients with major depression. The dropout rate was 21 percent for placebo and 30.2 percent for trazodone, with 4 percent of those patients discontinuing due to somnolence or sedation...

You may also be interested in...

Labopharm Tramadol-Acetaminophen Combo Could Offer Twice-Daily Dosing

Canadian firm initiates Phase III trial evaluating the combination for treatment of acute lower back pain

US FDA Puts All China Drug Inspections On Hold Due To Coronavirus Outbreak

February and March inspections deferred unless any are deemed mission critical. China director remains behind as staff evacuate.

Colgate Was Drawn To Hello Products’ Youthful Lifestyle Branding, And Now It Has A CBD Line

Successfully acquired by Colgate-Palmolive on 31 January, Hello quickly made a statement with the launch of a CBD oral-care range and its first go at lip care, CBD Vegan Lip Balm. Available exclusively through Ulta Beauty, the CBD products have the potential to score well with younger consumers interested in natural ingredients, eco-friendly packaging and, of course, cannabis-based innovations.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts