Durect received an untitled letter three weeks ago over the way it presented Remoxy ER on its website (pictured above).
Three weeks after the FDA’s Office of Prescription Drug Promotion warned two drugmakers about promoting an unapproved painkiller, the regulator declined to approve that drug.
Pain Therapeutics and Durect received a complete response letter on Monday for the company’s abuse-deterrent opioid Remoxy ER. The FDA concluded in the letter that the drug could not be approved based on the company’s current application.
Pain Therapeutics said in statement that the CRL “focuses on the abuse-deterrent properties of Remoxy ER and proposed drug labeling.” The company said it may cost $5 million and another year to resubmit the application to the FDA.
The rejection marks the third time that the FDA has declined to approve Remoxy ER. Durect developed Remoxy and licensed it to Pain Therapeutics for development and commercialization in 2002. The drug is designed to leave patients with a bad taste in their mouths if chewed rather than swallowed.
The FDA’s OPDP on September 8 sent an untitled letter warning Pain Therapeutics and Durect about the promotion of Remoxy ER on both drugmakers’ websites and writing that their presentation of the drug included statements that were “phrased as established facts” rather than acknowledging the experimental status of the drug.
The agency took umbrage over these statements saying that trying to “shape public impressions of the drug in the lead-up to its launch, before the FDA’s evaluation of the product is complete” raises considerable public health concerns and noted that these claims are “particularly irresponsible and alarming” because Remoxy is an opioid drug.