FDA to Review NDA for Opioid Analgesic Remoxy ER
Pain Therapeutics announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Remoxy ER (oxycodone extended-release) capsules for the treatment of severe chronic pain.
Remoxy ER is an abuse-deterrent, extended-release capsule formulation of oxycodone. Its thick, sticky, and highly viscous capsule formulation is intended to deter unapproved routes of administration, such as injection, snorting or smoking. Remoxy ER was designed to make oxycodone difficult to abuse while providing 12 hours of therapeutic effect when taken appropriately.
Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses; the principal therapeutic action of oxycodone is analgesia.
The Prescription Drug User Fee Act date has been set for August 7, 2018.
For more information call (512) 501-2444 or visit PainTrials.com.