FDA Brief: Week of Feb 8, 2016

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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.

Efficacy:

• 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).

Safety:

• 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

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