FDA’s Promotional Enforcement Still Playing It Safe

Supernus Pharmaceuticals Inc. is the fifth company to get cited by FDA this year for a misleading drug promotion, and while the criticism is typical the context is somewhat unusual.

The agency’s Office of Prescription and Promotion (OPDP) objected to a Key Opinion Leader Spanish video for Supernus’ seizure drug Oxtellar XR (oxcarbazepine). In an Oct. 31 untitled letter, FDA said the video presentation provides evidence that the drug is intended for a new use for which it lacks approval and creates a misleading impression about its safety and effectiveness.

Oxtellar XR is indicated for adjunctive therapy for partial seizures in adults and children six to 17 years of age. FDA said the video opens with statements by Dr. Jesus Eric Piña-Garza that suggest the drug is intended for use in treating all seizure types and is safe and effective for treatment of seizures other than partial seizures.

For example, FDA cites Piña-Garza’s statement: “Oxtellar XR is a medication that I frequently add to other medications when the epilepsy is not controlled or the person is having side effects” (FDA emphasis added).

FDA said the correct indication appears later in scrolling text and voiceover, but that this does not negate the earlier statements.

In addition, the agency said the opening segment conveys benefit claims but fails to disclose any specific risks associated with the drug.

“The presentation of risks associated with Oxtellar XR is relegated to the end of the video after Dr. Piña-Garza’s presentation, where it is unlikely to draw the viewer’s attention, as it is displayed in scrolling text with a voiceover,” the letter states. “The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”

The risks cited in the labeling include hyponatremia, anaphylactic reactions and angioedema, hypersensitivity reactions in patients with hypersensitivity to carbamazepine, serious dermatologic reactions, and suicidal behavior and ideation.

Harsh Criticism Of Remoxy Websites

Rockville, Md.-based Supernus submitted the video to FDA for review in November 2015. It is unclear if the company aired the video and if so, where it was available. The company could not be immediately reached for comment.

The specialty pharma company focuses on treatments for central nervous system disorders. Oxtellar XR is one of the company’s two marketed products. In the second quarter of 2016 it had 30,644 prescriptions and net sales of $12.7m.

FDA has issued a record low number of enforcement letters this year for prescription drug promotional pieces. The number has steadily declined since 2010 when the agency issued 51 letters. Last year OPDP sent nine letters, which tied with the number in 2104 after FDA withdrew its 2014 letter to Pacira Pharmaceuticals Inc. regarding the promotion of Exparel (bupivacaine liposome injectable suspension). (Also see "FDA's Rx Promotion Citation Drought Continued In 2015" - Pink Sheet, 4 Jan, 2016.)

OPDP’s most recent letter prior to Supernus’ was a Sept. 8 letter to Durect Corp. and Pain Therapeutics Inc. regarding their websites for Remoxy (oxycodone controlled-release). The agency said the sites suggested the investigational drug is safe and effective for purposes for which it is under investigation. Remoxy is a capsule that incorporates Durect’s Oradur technology. The agency strongly rebuked the companies for making promotional statements about the drug while it is under review.

“Conclusory statements regarding safety and effectiveness of a drug, made while an application for the product is under review, suggest an effort to shape public impressions of the drug in the lead-up to its launch, before FDA’s evaluation of the product is complete and reflected in approved drug labeling,” the letter states. “Such statements raise considerable public health concerns and may remain probative evidence later when a product is in broad distribution.”

Pain Therapeutics announced on Sept. 26 that it had received a “complete response” letter from FDA requiring new studies and data to support specific abuse deterrence claims. (Also see "Remoxy's Woes Stoke Criticism Of FDA's Review Of Abuse-Deterrent Opioids" - Pink Sheet, 30 Sep, 2016.)