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FDA Approves Therapy for Oral Ulcers Associated with Rare Disease

Apremilast (Otezla) was approved by the FDA for the treatment of adult patients with oral ulcers associated with Behçet disease. This is the first and only approved treatment for this condition.

Approval was based on data from the randomized, placebo-controlled Phase 3 RELIEF study that include 207 participants with active oral ulcers associated with Behçet disease. After 12 weeks of treatment, apremilast was associated with a 42.7-point reduction from baseline in pain or oral ulcers compared with 18.7-point reduction with placebo on the visual analogue scale. In addition, 52.9% of participants treated with apremilast achieved complete response after 12 weeks compared with 22.3% in the placebo group.
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The most common adverse events associated with apremilast treatment included diarrhea (41.3%), nausea (19.2%), headache 14.4%), and upper respiratory tract infection (11.5%).





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