PixarBio Corporation Announces Signed Agreement with Lubrizol’s Division, Particle Sciences, to cGMP Manufacture NR14 for Clinical Trials, a 14 Day Post-Surgical Pain Treatment
SALEM, N.H.--(BUSINESS WIRE)-- PixarBio Corporation developers of NeuroRelease™ NR14, a 14-day post-surgical pain treatment, announces an agreement between Particle Sciences (PSI), a Lubrizol 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.
About PixarBio Corporation
PixarBio is a specialty pharmaceutical/biotechnology company focused on pre-clinical and clinical commercial development of novel neurological drug delivery systems for post-operative pain. PixarBio researches and develops targeted delivery systems for drugs, devices, or biologics to treat pain, epilepsy, Parkinson’s disease, and spinal cord injury. Our lead product platform, NeuroRelease™, has achieved sustained therapeutic release of non-opiate drugs for post-operative, acute and chronic pain in pre-clinical models. For more information, visit www.pixarbio.com.
CIO and VP, External Communication & Investor Relations
Source: PixarBio Corporation