Treatment of back pain, innovative painkillers, phase 3 clinical results
November 30, 2017 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Egalet recently announced the results of its second phase 3 clinical trial of its low back pain drug Egalet-002. The study evaluated the efficacy and safety of the anti-abuse slow release oxycodone Egalet-002 developed using GuardianTM technology. This is the second of two Egalet Phase 3 clinical studies for placebo-controlled multicenters in patients with moderate to severe chronic low back pain, including those who have taken opioids and have not used opioids. , double-blind, enriched recruitment, randomized withdrawal efficacy and safety studies.
Egalet's proprietary Guardian technology is a polymer matrix tableting technology that uses injection molding special manufacturing processes to produce tablets that are difficult to abuse. These tablets not only release the drug, but also resist common drug abuse operations such as cutting, crushing, and grinding using various mechanical and power tools. They are also resistant to chemical extraction and become viscous hydrogels when in contact with liquids, making them non-injectable.
The study reached the primary end point and the results showed a statistically significant difference (p < 0.0001) between the Egalet-002 and placebo groups from baseline (randomized time point) to week 16 mean pain intensity. In the previously published Phase 3 safety study, Egalet-002 was generally well tolerated and no new safety issues were identified in this study.
â–² Mr. Bob Radie, President and CEO of Egalet (Source: Egalet's official website)
Mr. Bob Radie, President and CEO of Egalet, said: "These results indicate that the anti-abuse slow-release oxycodone Egalet-002 can relieve pain in patients with moderate and severe chronic low back pain. Given the wide range of chronic low back pain and prescription abuse Popular, we believe that it is important to develop more anti-abuse painkillers such as Egalet-002."
Reference materials:
[1] Egalet Surges as Back Pain Drug Meets Goals in Phase III Trial
[2] Egalet's official website
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