Regulatory Update
The FDA approved vonoprazan in combination with amoxicillin and clarithromycin (Voquenza Triple Pak, PhathomPharmaceuticals) and in combination with amoxicillin alone (Voquenza Dual Pak, Phathom Pharmaceuticals), on 5/3/2022, for the treatment of Helicobacter pylori infections. Announced Research Updates Astellas announced that in the 12-week, 501 patient, Phase III, SKYLIGHT 1 trials, patients treated with fezolinetant reduced the severity of moderate to severe VMS by 0.15 points at 4 weeks and 0.24 points at 12 weeks with 30 mg and 0.19 points at 4 weeks and 0.20 points at 12 weeks with 45 mg compared to placebo in patients with moderate to severe VMS. The frequency of moderate to severe VMS events per day versus placebo was reduced by 1.87 episodes at 4 weeks and 2.39 episodes at 12 weeks with 30 mg and 2.07 episodes at 4 weeks and 2.55 episodes at 12 weeks with 45 mg compared to placebo. Comments are closed.
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