PixarBio Corporation Clarifies Pathways to FDA Approval for NR14 to Treat “Trigeminal Neuralgia” and Post-Surgical Pain
We want to clarify any confusion with respect to our early 2016 decision to terminate the US FDA Orphan Drug Designation application process for TN. In January 2016, we had decided to prioritize NR14 with a US FDA New Drug Application (NDA) approval pathway for post-surgical pain vs. NR14 as an Orphan Drug Designation (ODD) US FDA approval pathway for Trigeminal Neuralgia NR14. We believe that NR14 will be able to treat pain, for the most common TN patient groups who suffer from TN.
The post-surgical pain market exceeds 90,000,000 surgeries per year. Trigeminal Neuralgia is a fragmented market, but it is believed to effect between 65,000 - 275,000 patients living in the USA. We believe clinical studies will prove that NR14 will safely provide benefit to both severe pain conditions TN and PSP so we intend to file two separate NDA’s.
We intend to file a US FDA NDA in late 2019 for NR14 to treat the estimated 90,000,000+ annual post-surgical pain (PSP) patients in the USA. We also intend to file an NDA in early 2020 for NR14 to treat Trigeminal Neuralgia.
According to NIH’s National Institute of Neurological Disorders & Stroke (NINDS) Trigeminal neuralgia (TN), also called tic douloureux, is a chronic pain condition that affects the trigeminal or 5th cranial nerve, one of the most widely distributed nerves in the head. TN is a form of neuropathic pain often associated with nerve injury or nerve lesion.
“Management believes NR14 will become an important treatment in pain management to 'break the cycle of pain' for both TN and PSP chronic pain markets,” 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 is anticipated in late 2019 for a 14-day post-surgical pain treatment.
About PixarBio Corporation
Our lead R&D 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