The U.S. FDA accepted for filing IntelliPharmaCeutics International Inc.'s new drug application seeking approval to market various strengths of Rexista, a painkiller.
Rexista is an abuse-deterrent opioid analgesic for the treatment of moderate to severe pain.
The FDA determined that the company's application is sufficiently complete to permit a substantive review and set a target action date of Sept. 25 under the prescription drug user fee act.
The submission is supported by pharmacokinetic studies that demonstrated that Rexista is bioequivalent to OxyContin. It also includes abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous.