QRX 0.00% 2.8¢ qrxpharma ltd

abuse deterrents

  1. 1,057 Posts.
    FDA are considering giving opioid NDAs with abuse deterrents priority review as one means of incentivizing drug developers to make safer pain killers. While the FDA won't announce final measures until May, it's good to see this as a possible inclusion.

    For QRX this would mean less time and money needed to get MoxDuo into the market and revenues received sooner.

    From this article...
    https://www.raps.org/focus-online/news/news-article-view/article/2711/fda-leaning-toward-requiring-generic-opioids-to-contain-abuse-deterrent-qualiti.aspx

    ''First, Hamburg noted that products with abuse-deterrent formulations would likely be given fast-track or priority review status to "encourage the development and to speed the approval process of such products," providing a strong incentive for companies to include abuse-deterrent qualities in their products. Fast-track and priority review processes can significantly speed up review times, generally aiming for an approval decision within six months. This can sometimes halve the amount of time taken to receive an approval decision—a huge benefit for generic products looking to establish a foothold in a market no longer dominated by a single competitor.''
 
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