PixarBio Corporation developers of NeuroRelease NR14, a 14-day post-surgical pain treatment, announces an agreement between Particle Sciences (PSI), a Lubrizol Corporation Company, to cGMP manufacture PixarBio’s NR14 product for clinical trials. In 2018, PixarBio will be able to apply to the US FDA for fast track approval through the CDER Breakthrough Therapy designation.
“Although the agreement covers our 14 day treatment, we also have a 7 and 3 day product in our pipeline that are not part of this agreement. We worked for over 3 years with PSI to put this agreement in place and look forward to a long term collaboration. I am confident that with the FDA’s fast track approval we can receive FDA clearance to market NR14 in late 2019,” said CEO Frank Reynolds.
The NeuroRelease Platform: Non-Addictive and Non-opiate Treatment of Pain NeuroRelease is a morphine replacement, and non-addictive pain platform for post-surgical pain. First product FDA approval for the platform will be for a 14-day post-surgical pain treatment and it is expected in late 2019. The platform can be formulated for acute and chronic pain treatments.