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  USA Approved Drugs 2017
 

New Drugs 2017

Trulance (plecanatide)- Synergy

Trulance was approved January 2017 for the treatment of adults with Chronic Idiopathic Constipation (CIC). Trulance, a guanylate cyclase-C agonist, is the first drug in its class and replicates the function of an endogenous human gastrointestinal peptide, uroguanylin, which is thought to stimulate fluid secretion. Trulance was studied for safety and efficacy in two Phase 3, placebo-controlled, randomized trials in 1,775 patients for 12 weeks. Participants were those diagnosed with constipation 6 months or more before the study and had 3 or less defecations per week in the last three months. Results showed patients taking Trulance experienced improvement in complete spontaneous bowel movements and improvement in stool frequency, consistency, and straining. Diarrhea was the most common side effect reported. The recommended dosage is 3 mg taken by mouth once daily.

Rhofade (oxymetazoline hydrochloride)-Allergan

Rhofade was approved in January 2017 for the treatment of persistent facial erythema in adult patients with rosacea. Rhofade is the first alpha 1A adrenoceptor agonist approved for this indication and will be available as a 1% topical cream. Rhofade, once daily, was studied in two, randomized, double blind, multi-centered trials in adults that showed a reduction in persistent facial erythema through 12 hours. The most common side effects were application site dermatitis, worsening of inflammatory lesions, pruritus, erythema, and pain.

 


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