IGXT IntelGenx Technologies Corporation (PK)

By Robb M. Stewart

IntelGenx Corp. said Thursday its partner will address concerns this quarter being raised by the U.S. Food and Drug Administration in a complete response letter to an abbreviated new drug application for Buprenorphine Buccal Film, a generic version of an opioid used to manage chronic pain.

The Canadian drug-delivery company said co-developer Chemo Research SL received the FDA's review of the data submitted in the application, and the pair will contact the agency to discuss the letter and assess the filing of a request for reconsideration of the complete response letter.

Earlier this month, IntelGenx said the FDA approved the company's Rizafilm new drug application for the treatment of acute migraine.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

April 27, 2023 08:32 ET (12:32 GMT)

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