FDA accepts NDA for Remoxy ER an abuse deterrent extended release formulation of oxycodone for pain control.-Pain Therapeutics.

Pain Therapeutics, Inc. announced that the FDA has determined that a New Drug Application (NDA) for Remoxy ER, the Company�s lead drug candidate, is sufficiently complete to permit a substantive review. The FDA has set an action date of 7 August, 2018 under the Prescription Drug User Fee Act (PDUFA). The Company believes the FDA will hold an open advisory committee meeting to discuss Remoxy ER, although a date has not yet been determined.

Remoxy ER is an abuse-deterrent, extended-release, capsule formulation of oxycodone (CII), a prescription drug for severe pain. Remoxy ER has a thick, sticky, high-viscosity capsule formulation designed to deter unapproved routes of drug administration, such as injection, snorting or smoking. Pain Therapeutics developed Remoxy ER to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients with pain.