| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers L > Headlines for LAB International Inc. > News item |
LAB International: Fentanyl Taifun reduces breakthrough cancer pain in phase 2a trial
By Lisa Kerner
Charlotte, N.C., July 12 - LAB International Inc. said results from the phase 2a trial of its lead product, Fentanyl Taifun for breakthrough cancer pain, support clinical efficacy at the lowest dose of 100 micrograms and reducing pain in less than 12 minutes, on average.
While the safety of Fentanyl Taifun was similar to that of a placebo, there was an increase in mild to moderate somnolence.
A total of 122 cancer patients on maintenance opioid therapy for persistent pain were enrolled in the multi0centered, randomized, double-blind, placebo-controlled, parallel group trial.
Primary efficacy variables of the trial were the time to significant pain relief and the degree of pain relief as measured by the Sum of Pain Intensity Difference.
Fentanyl Taifun was administered by inhalation at doses of 100, 200 and 400 mcg per dose during two episodes of breakthrough pain.
Protocol violators and patients that received rescue medication were excluded from the results.
Significant pain relief was achieved on average in 7.8 to 11.6 minutes, with statistically significant differences with the 100 mcg and 400 mcg doses.
The degree of pain relief was significantly better with Fentanyl Taifun compared to a placebo, even at the 100 mcg dose.
"Our product has been demonstrated to provide instantaneous availability of fentanyl in the blood within one minute after inhalation and may provide more rapid pain relief than any existing non-injectable pain medication, as demonstrated by the time to significant pain relief," chief executive officer Halvor Jaeger said in a company news release.
"The speed of analgesia with Fentanyl Taifun is approaching the theoretical minimum of 3 to 5 minutes observed with intravenous administration of fentanyl."
LAB is an integrated drug development company based in Lavel, Quebec.
© 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.