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Pain Therapeutics Resubmits New Drug Application for REMOXY ER
Feb. 13, 2018 09:14AM PST
Pharmaceutical InvestingPain Therapeutics (Nasdaq:PTIE) announced today the resubmission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for REMOXY® ER, its lead drug candidate. The Company expects a six-month review cycle by FDA. As quoted in the press release: Pain Therapeutics developed REMOXY ER as an abuse-deterrent, extended-release, capsule formulation of oxycodone, …
Pain Therapeutics (Nasdaq:PTIE) announced today the resubmission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for REMOXY® ER, its lead drug candidate. The Company expects a six-month review cycle by FDA.
As quoted in the press release:
Pain Therapeutics developed REMOXY ER as an abuse-deterrent, extended-release, capsule formulation of oxycodone, a prescription drug for severe pain. REMOXY ER is designed to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients with 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.
