Cipher expects to file NDA for pain medication

By Lisa Kerner

Erie, Pa., Jan. 27 - Cipher Pharmaceuticals Inc. said it expects to file a New Drug Application with the Food and Drug Administration in the second quarter of 2006 for CIP-Tramadol Extended Release (ER), its once-daily, sustained release formulation of the pain medication tramadol.

"The fact that our existing data meets the requirements to file with the FDA now allows us to complete the preparation of the submission and moves us one step closer toward commercialization of CIP-Tramadol ER," Cipher president Larry Andrews said in a company news release.

"We intend to complete our ongoing phase 3 study to further support both the regulatory and commercial success of the product."

Cipher said it completed enrollment of its ongoing phase 3 efficacy trial (the 02.05 trial) of CIP-Tramadol ER. Results are expected to be available in the third quarter of 2006.

Results from a phase 1 trial investigating potential interaction between CIP-Tramadol ER and high levels of alcohol are also expected during the third quarter.

Cipher's capsule formulation of tramadol has demonstrated both rapid absorption and an extended release profile over a 24-hour timeframe in biopharmaceutical trials. The product demonstrated comparable bioavailability under both fed and fasted conditions, the company said.

Cipher Pharmaceuticals is a drug development company based in Mississauga, Ont.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.