FDA Approval of Sernivo
FDA Brief: Week of Feb 8, 2016
Sernivo (betamethasone dipropionate) Spray, 0.05%
Promuis Pharma, Princeton, New Jersey, USA
Indication: treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Reg Pathway: 505 (b)(2)
Mechanism of Action: Steroid. Precise mechanism of action of spray in psoriasis is unknown.
- 2 multi-center, randomized, double-blind; moderate plaque psoriasis; 28 days; Sernivo vs. Vehicle
- Primary Endpoint: Investigator Global Assessment (IGA) score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline
- Treatment success of 42.7% and 34.5% vs. 11.7% and 13.6%, respectively (p<0.001).
- Warnings/Precautions: Reversible HPA axis suppression, Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes mellitus
- Most common adverse reactions : Application site reactions, including pruritus, burning and/or stinging, pain, and atrophy