CAMBRIDGE, Mass.--(BUSINESS WIRE)--PixarBio Corporation today announced that it has filed an application with the US FDA Office of Orphan Products Development, for orphan drug status of our NeuroRelease TN (NR-TN) drug candidate for the treatment of Trigeminal Neuralgia (TN).
“Anticipated FDA approvals in 2017, for NeuroRelease’s core pain indications covering knee, hip and shoulder pain remain PixarBio’s primary R&D focus. However, Trigeminal Neuralgia patients suffer severe facial pain with unpredictable onset, intensity, and duration while developing drug resistance to the current gold standards of care. The need for new TN treatment is clear. As we extended our NeuroRelease platform to acute and chronic pain we knew Trigeminal Neuralgia was a patient population that could benefit from NeuroRelease,” said PixarBio CEO Frank Reynolds.
The USFDA grants Orphan Drug Designation status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
A successful designation of NeuroRelease as an Orphan Drug would provide PixarBio with a 7-year period of market exclusivity in the U.S. upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The decision to seek an Orphan Drug Designation submission is part of PixarBio’s plan to move forward with the preparation of an Investigative New Drug Application (NDA) for Trigeminal Nerve Pain.
About PixarBio Corporation
Cofounded by Frank Reynolds, MIT’s Dr. Robert S. Langer, Katrin Holzhaus, and Jason Criscione, PixarBio is focused on researching and developing targeted delivery systems to treat pain, epilepsy, Parkinson’s disease, and spinal cord injury. For more information visit www.pixarbio.com.
Contacts
PixarBio Corporation
Glenn Reiser, 617-386-6795
Investor Relations
greiser@pixarbio.com
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