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Pain Therapeutics, Inc. announced it plans to meet with the U.S. Food and Drug Administration (FDA) in person on Monday, February 13, 2017 to discuss the regulatory path forward for REMOXY ER. The Company will provide details of this FDA meeting after receipt of final meeting minutes.
Pain Therapeutics is committed to working with the FDA to gain regulatory approval of REMOXY ER. During its upcoming meeting with the FDA, the Company plans to open a scientific dialogue around the intranasal (snorting) route of abuse. REMOXY ER is a gel formulation that is not suitable for deep inhalation. The Company believes REMOXY ER's thick, sticky, high-viscosity drug mass is a key feature of its abuse deterrent properties, recognizing that no drug can be made abuse-proof.
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY ER to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY ER's thick, sticky, high-viscosity gel formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. REMOXY ER targets the multi-billion marketplace for long-acting oxycodone.
