FDA Approves Otezla (Apremilast) to Treat Oral Ulcers

The FDA has approved Otezla (apremilast, Celgene) for the treatment of oral ulcers associated with Beçhet’s Disease, a rare disorder that causes vasculitis throughout the body. 

Apremilast is a phosphodiesterase 4 inhibitor that was originally approved in 2014.

Approval for the indication comes from the results of a phase 3 randomized placebo-controlled double-blind studythat evaluated Otezla 30 mg twice a day in 208 adult patients with Behçet’s Disease. This dosage reduced pain of oral ulcers as measured on a visual analog scale at week 12 by 42.7 points from baseline; the placebo reduced by 18.7 points from baseline. 

At week 12, 52.9% of patients receiving apremilast achieved oral ulcer complete response, compared with 22.3% of the patients in the placebo arm. 

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At week six, 29.8% of patients in the apremilast arm achieved oral ulcer complete response and remained ulcer free for an additional six weeks, compared with 4.9% of patients in the placebo arm. 

Daily average total number of ulcers during treatment were: 1.5 in the apremalist arm, 2.6 in the placebo arm. 

“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, MD, Clinical Associate Professor, Department of Medicine, New York University Langone Health, in a prepared release. “In the clinical trial, Otezla demonstrated improvements in measures of oral ulcers at week 12. Otezla has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available.”

Apremilast is contraindicated for patients with a known hypersensitivity to the active ingredient or any excipients in formulation. 

Adverse events reported throughout Behçet Disease clinical trials included diarrhea, nausea, headache, and upper respiratory tract infection. 

See the full prescribing information for more information on all warnings, including: diarrhea, nausea, and vomiting; depression; weight decrease; and drug interactions. 

Full Prescribing Information