The FDA wrote in an untitled letter that Durect’s presentation of certain benefits on its website (FDA-provided screengrab above) suggests the drug has already been approved.
The FDA’s Office of Prescription Drug Promotion warned two drugmakers for promoting an experimental drug with language that suggests it has been already approved.
Pain Therapeutics and Durect received an untitled letter on September 8 over what the FDA says is misleading promotion of their investigational drug, Remoxy ER, which is an abuse-deterrent formulation of the pain treatment oxycodone.
The FDA uses untitled letters to warn drugmakers about their promotional activities for less serious violations — it reserves warning letters for more significant infractions.
Regulators wrote that Durect’s website includes statements about the drug that were “phrased as established facts,” including that the drug is “long-acting “ and “tamper-resistant.” The FDA explained that this promotion suggests that the drug is safe and effective even though it has not been approved.
Pain Therapeutics’ presentation of the drug also came under scrutiny. The agency said that the drugmaker’s website states that Remoxy resists injection or snorting. The OPDP officials wrote 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 statements are “particularly irresponsible and alarming” because Remoxy is an opioid drug.
This warning marks the third untitled letter sent by the agency this year. In addition, it has issued one warning letter so far this year. The FDA also sent a letter to Jazz Pharmaceuticals in early September over the promotion of an experimental drug.
The FDA has twice rejected Remoxy for approval. Another FDA decision date is scheduled for September 25.
Durect developed Remoxy and licensed it to Pain Therapeutics in 2002. The drug is designed to leave patients with a bad taste in their mouths if chewed rather than swallowed.
Pain Therapeutics and Durect did not immediately respond to inquiries.