Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials.
The agency based its decision on data from three Phase I trials that showed Rexista XR (abuse-deterrent oxycodone hydrochloride) to be bioequivalent to OxyContin (oxycodone), the firm said Thursday.
The waiver is expected to save Intellipharmaceutics about $19 million, Chief Financial Officer Domenic Della Penna tells DID. Phase III trials would have cost roughly $20 million, whereas filing the NDA will cost no more than $1 million.
Rexista XR is not a generic, the company stresses. Intellipharmaceutics took advantage of the 505(b)(2) pathway, which allows it to submit an NDA for a new drug based off a reference product. In this case, the reference product is Purdue Pharma’s OxyContin, Della Penna says.
Rexista XR adds a few abuse-deterrent features that OxyContin does not, he adds, which qualifies it as a new drug. It is designed to prevent dose dumping when mixed with alcohol and immediately clumps when crushed, pulverized or hydrated.
If approved, the 505(b)(2) pathway will provide Rexista XR five years of marketing exclusivity. Should the drug make it to market, Intellipharmaceutics intends it for managing moderate to severe pain in patients who need round-the-clock analgesics. — Lena Freund