Navigation Links
Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Acetaminophen
Date:3/10/2008

- Formulation Has Potential to Address Large Acute Pain Prescription Drug

Market -

LAVAL, QC, March 10 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has begun enrolling patients in its Phase III clinical trial for its twice-daily, tramadol-acetaminophen combination product (study 06CCL3-001).

"Tramadol-acetaminophen combination products have become widely prescribed based on their ability to provide the analgesic potency of tramadol and the rapid efficacy of acetaminophen, as well as their use in treating a broad spectrum of pain types," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Our formulation has the potential to be the first twice-daily tramadol-acetaminophen product, as well as to compete in the broader acute pain prescription drug market globally. Accordingly, it would be an excellent complement to our once-daily tramadol product for the treatment of persistent pain."

Currently marketed tramadol-acetaminophen combination products must be administered four- to six-times per day. Labopharm believes that by metering the release of both tramadol and acetaminophen from a single tablet using its Contramid(R) controlled-release technology, its formulation has the potential to offer enhanced patient compliance through twice-daily administration, as well as a potentially improved side effect profile. More importantly, based on its potential potency, efficacy, safety and convenience, the Company's novel formulation of tramadol-acetaminophen could be well positioned as an alternative to other prescription products for the treatment of mild to moderate acute pain, including mild-opioids, tramadol, COX-2 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs) and combination forms of these products.

Study 06CCL3-001 is a multi-centre, randomized, double-blind, parallel-arm study that will compare the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen combination product to placebo in the treatment of acute low back pain. The study, which is being conducted at more than 20 centers in the U.S. and Canada, has a treatment period of approximately one week and is expected to include more than 250 patients.

About the Acute Pain Prescription Market

The number of prescriptions written for acute pain products (mild-opioids, tramadol, COX-2 inhibitors, non-steroidal anti-inflammatory drugs and combinations forms of these products) in the U.S. alone in 2007 grew to 290 million and accounted for sales of US$9.0 billion.

About Tramadol-Acetaminophen Combination Products

Tramadol-acetaminophen combination products offer the analgesic strength of tramadol and the rapid analgesia of acetaminophen in a single tablet. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the US and the symptomatic treatment of moderate to severe pain in the rest of the world. Tramadol-acetaminophen combination products are currently available only in formulations that must be administered four- to six-times per day.

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 lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become a fully integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit http://www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the outcomes of clinical trials, to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.


'/>"/>
SOURCE Labopharm Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
2. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
3. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
4. Labopharm appeals FDAs decision on once-daily tramadol
5. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
6. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
7. Labopharm Reports Results for Third Quarter Fiscal 2007
8. Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
9. Labopharm enters into licensing and distribution agreement for once-daily tramadol in Australia with iNova
10. Canadian Marketing and Sales Effort for Labopharms Once-Daily Tramadol Product to Expand Significantly
11. Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... California (PRWEB) , ... June 26, 2016 , ... Pixel ... Cut Pro X. , "Film editors can give their videos a whole new perspective ... Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over ...
(Date:6/26/2016)... ... , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a ... fitness app plans to fix the two major problems leading the fitness industry today:, ... type program , They don’t eliminate all the reasons people quit their exercise ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
Breaking Medicine Technology: